Position Summary:

This position requires both technical and interpersonal skills. As a main point of contact and support for the entire IT organization, the analyst must be able to explain technical issues to non-technical users. Primary duties of the System Support Analyst III include assessing incidents and requests and resolving issues. In particular this analyst will work to complete many routine activities as well as to resolve service issues with little guidance. The analyst will contribute in team meetings on how to improve the performance, stability, cost effectiveness and serviceability of IT client systems. The Analyst also participates in other desktop system work such as configuring and deploying new systems, maintaining existing hardware and software and assisting in employee moves.

Responsibilities:

• Solve or escalate incidents and requests as required to ensure quality service and resolution within established service targets. This includes, support and manage (1) Desktops, laptops, mobile devices and shared resources such as printers, shared workstations, conference rooms, projectors and telephones (2) Remote users via phone and remote management software which includes VPN, Terminal Services and Remote desktop connections (3) Videoconferencing equipment (4) Ipad, Iphones, android based devices and Blackberries
• Build, configure, maintain (patch), repair and manage new and existing systems for employees, (1) Develop, maintain and deploy standard system images (2) Develop, maintain and deploy software distribution packages.
• Coordinate with various IT groups in resolving incidents and fulfilling requests based on established guidelines. Ensure Service Level Agreement performance standards are met.
• Ensure that all interactions are documented via the electronic service request management software with clear technical descriptions of incidents / requests, work done to resolve, root causes and indicating all client interactions.
• Recommend and produce procedures and standards to improve the quality and delivery of service to customers.
• Assist in requirements definition, research, and implementation for new client computing solutions.
• Generate customer facing documents. Desk guides, training aids, quick reference guides and other aids to make customers self sufficient.
• Maintain IT equipment inventory. Perform necessary change of status transactions to reflect the addition, move or retirement of IT assets.

Qualifications:

• Minimum 10 years experience providing end user assistance in a networked Windows environment (1) 3 year help desk, service desk, or support center experience (2) 2 years desk side support in a Windows/Intel environment (Dell/Lenovo experience a plus)
• Installing, configuring, troubleshooting and supporting Windows applications. Knowledge of Microsoft Office applications is required, including Outlook, Word, Excel, PowerPoint and Visio.
• Supporting Intel based desktop and laptop hardware. Ability to troubleshoot issues with peripherals, communication issues, etc.
• Supporting mobile devices, (Smartphones, Android based devices, iPhone or similar).
• Supporting all levels including VP or C-level executive staff is mandatory.
• Troubleshooting video conferencing equipment. (Cisco preferred)
• Supporting technology solutions such as projectors, presentation workstations, printers, copiers, scanners, and Fax machines.
• Certifications in Microsoft, HDI, A+, ITIL certifications/training or equivalent experience required.
• Customer service: Must be able to deliver service to a calm and professional manner when dealing with trying situations or with demanding customers. Consistent follow through on solutions to ensure issues are resolved.
• Strong communications skill. Ability to clearly communicate with customers using appropriate non technical explanations. Excellent verbal and written communication skills are required.
• Must be able to develop and maintain a positive rapport with all customers. This rapport will be built on the analyst having the requisite technical and communication skills.
• Troubleshooting-must be able to face high pressure situations where something is not working and they are expected to rapidly anaylze and resolve it.

Position Must Be Filled By April 15, 2016, So Apply Soon!

Summary:

Individuals in this position will work with business users, other SAP Business Analysts, developers and internal IT team members on the implementation, support and enhancement of the SAP module for which they are responsible. SAP Business Analysts will serve as the functional lead for their assigned department(s). They will apply proven communication, analytical and problem solving skills to help maximize the benefit of SAP in the client environment.  Assignments are complex in nature where considerable judgment and initiative are required in resolving problems and making business process recommendations.

Essential Duties/Responsibilities:

• Develop strong partnerships with the Quality, Manufacturing, and Engineering departments in order to understand the strategic direction, business processes and business needs of the business areas and recommend processes and/or functionality in SAP that can be used to meet the requirements.
• Provide production support through design, development, testing and implementation of appropriate system configurations within primary modules of responsibility, specifically, Quality Management (QM), Materials Management (MM/WM), Production Planning (PP), and Plant Maintenance (PM), to effectively meet business requirements.
• Prepare detailed design documents, functional specifications for development activities including reports, interfaces, conversions, enhancements, and forms. Follow all internal standards and change control procedures in performing required work.
• Perform testing activities (unit, conference room pilots, integration and user acceptance testing), including test plan creation and data and test execution (in conjunction with the other functional team leads).  Promote transports to quality assurance and production.
• Prepare training materials and perform end-user training for newly implemented functionalities and enhancements.

Qualifications:

• Bachelor’s Degree  in Computer Science, Information Systems, or related discipline.
• 8-12 years of experience in  extensive configuration in MM, PP, QM and PM modules required in SAP ECC 6.x.
• Experience working with 3rd party solutions specific to the area of expertise
• Team Lead experience required
• Knowledge of entire SAP landscape for supported processes
• Experience in multiple SAP implementations preferred (at least three successful, full life cycle implementations required, preferable in a pharmaceutical environment)
• Basic understanding of ABAP programming with debugging skills.  Must have very good knowledge of working with user exits
• Strong working knowledge of Microsoft Applications (PowerPoint, Excel, Word)
• Experience within a manufacturing environment regulated by the FDA preferred
• Experience with computer systems’ validation preferred
• SAP certification preferred

Position Must Be Filled By April 15, 2016, So Apply Soon!

Position Summary:
The Senior Business Analyst, Quality Systems (IT) position will be responsible for defining, designing, and delivering information technology solutions in a validated environment for the Quality, R&D and Manufacturing areas, with primary responsibility for EDMS systems. The Analyst will be responsible for documenting functional requirements and solution specifications, interacting with both Business users and IT resources. The Analyst will also be responsible for the administration of Veeva Vault including overseeing the managed services vendor aiding in that support. The Analyst should be familiar with the principles of computer systems validation, project and SDLC methodologies.

Responsibilities:
• Work with internal business clients to document business requirements for EDMS solutions and applications interfaced with it.
• Analyze current processes, and document configuration, application functionality and integration modifications needed to support business requirements.
• Create SDLC project deliverables including design, configuration, and testing.
• Work with software vendors to understand existing and future release functionality.
• Execute and document testing and work with team members for problem resolution.
• Provides technical assistance to users inquiries regarding errors, problems or questions.
• Perform Quality Assurance validation on requirements based software applications.
• Escalate incidents and requests as required to ensure quality service and within established service targets.
• Participate in after-hours on-call support rotation as required.
• Provide technical and procedural direction to team during manager’s absence
• Participate in knowledge transfer activities to relevant support teams for implemented solutions.

Requirements:
• 2-5 years of relevant IT experience supporting / developing systems solutions to business requirements
• 2-5 years of supporting or implementing enterprise software in a regulated (preferably Pharmaceutical/BioTech/ Medical Device) industry.
• 2-5 years of understanding of IT Quality Methodology and Change Management, including processes and tools.
• Previous Application Maintenance / Support experience a must.
• Experience with systems supporting Trackwise is a plus
• College degree (or equivalent experience)
• 2-5 years of previous EDMS experience – min 3 years. Veeva Vault experience is a plus
• 2-5 years of previous Application Maintenance / Support experience a must.
• 0-2 years of Previous Application Maintenance / Support experience a must.
• 0-2 years of Previous Application Maintenance / Support experience a must.
• 0-2 years of IT Certifications/training or equivalent experience is a plus.

Position Must Be Filled By April 15, 2016, So Apply Soon!

Position Summary:

The IT Senior Manager, R&D and Quality Systems is responsible for implementing and supporting R&D and quality business systems required for drug development in the cGMP environment. This position is responsible for the business analysis, planning, project management, implementation, computer systems validation and ongoing support of business applications in the areas of Research & Development Analytical, Regulatory Affairs, Clinical, Quality Affairs and Quality Control. The position has the responsibility of building a team and managed service model for support of these business systems and is the primary interface between IT and the R&D and Quality business teams. This position reports to the Director, IT Business Services.

Responsibilities:

• Work with business users to improve existing processes to allow them to be automated and recommends business / technology solutions to various functional areas.
• Assists implementation, administer methods and procedures to enhance operations based on industry best practices
• Manages the application support of R&D and Quality systems to ensure they meet business needs and user requirements, remains in compliance per cGMP requirements and GAMP5 guidelines.
• Ensure compliance with (1) FDA regulations related to IT infrastructure (2) Ensure compliance with FDA 21 CFR Part 11 in applications (3) Ensure compliance with SOX controls by all technical staff
• Provide IT oversight for GXP computer systems validations per GAMP5 guidelines and apply risk based methodology to validation efforts.
• Follow processes and operational policies in selecting methods and techniques for obtaining solutions.
• Ensures budgets, user requirements, and schedules meet department expectations and business requirements or escalate before situation is critical.
• Helps to develop resources and innovation to match the client’s continued growth in IT.
• Responsible for providing regular performance and development feedback to direct reports
• Manage Service Level Agreement’s with customers and vendors.

Requirements:

• 8-12 years of experience with a minimum of 10+ years of previous experience in system development, integration and laboratory work in the pharmaceutical or biotech industry is required.
• Requires a minimum of 5 years previous management experience.
• Experience with laboratory automation systems / instrumentations in a pharmaceutical environment.
• Experience with R&D, Brand, Quality Assurance / Quality Control, Regulatory Affairs, Clinical, Manufacturing environments regulated by the FDA.
• Experience with laboratory automation systems / instrumentations in a pharmaceutical environment.
• Experience with computer network validation
• International experience with implementing quality systems.
• Experience with VMware in a regulatory environment.
• Bachelor degree in Computer Science, Information Systems, or related discipline at a minimum. Master’s Degree is preferred.
• Experience with full system development life cycle, project management in large system, enterprise scale, implementation projects and laboratory automation applications.
• Solid knowledge of network and computing systems is essential.
• Experience with Waters CDS, Trackwise, LIMS, Electronic Regulatory Filing System, Document Management, Quality Systems, Laboratory Operations.
• Experience with computer systems validation.

Position Must Be Filled By April 15, 2016, So Apply Soon!

Summary of Duties and Responsibilities

This position reports to the Director – IT Infrastructure Services and plans, executes, and finalizes IT infrastructure projects according to deadlines and within budget. This includes acquiring resources and coordinating the efforts of team members and third-party contractors or consultants in order to deliver projects according to plan. The Project Manager will also define the project’s objectives and oversee quality control throughout its life cycle.

Key Accountabilities

Direct and manage project development from beginning to end.
Estimate the resources and participants needed to achieve project goals.
Develop full-scale project plans and associated communications documents.
Identify and manage project dependencies and critical path.
Plan and schedule project timelines and milestones using appropriate tools.
Track project milestones and deliverables.
Set and continually manage project expectations with team members and other stakeholders.
Liaise with project stakeholders on an ongoing basis.
Draft and submit budget proposals, and recommend subsequent budget changes where necessary.
Determine and assess need for additional staff and/or consultants and make the appropriate recruitments if necessary during project cycle.
Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.

Requirements
8-12 years of experience in a project management capacity, including all aspects of project execution.
Bachelor’s Degree in a related field is ideal.
Strong familiarity with project management software, such as MS Project.
Database and operating systems experience with Microsoft Technologies. Experience managing IT infrastructure related projects.

Position Must Be Filled By April 15, 2016, So Apply Soon!

Position Summary:
This position requires both strong technical and interpersonal skills. The position will support the clients enterprise client management product suite, including anti-virus, automated software deployment, imaging and scripting tools. Coordinate with members of the client’s Service Desk and Network Systems Engineering teams to ensure the efficient, timely delivery of software updates and patches

Position Summary:

This position requires both strong technical and interpersonal skills. The position will support the client’s enterprise client management product suite, including anti-virus, automated software deployment, imaging and scripting tools. Coordinate with members of the client’s Service Desk and Network Systems Engineering teams to ensure the efficient, timely delivery of software updates and patches. The individual must make independent and well executed judgments in researching, developing, and deploying effective solutions. They must ensure proposed changes to the enterprise client environment are fully tested and follow the client’s Change Management and Configuration Management policies and procedures, and serve as the centralized communication point for desktop anti-virus activities. The Network Administrator III will manage desktop hardware and software standards for the client.

Responsibilities:

-Solve incidents and requests or refer to other IT groups when necessary. Ensure that all interactions are documented via the electronic service request management software with clear technical descriptions of incidents / requests, work done to resolve, root causes and indicating all client interactions.

-Conduct detailed evaluations of new technology and educate IT staff on merits, weaknesses and recommendation on adoptability for the client.

– Manage automated deployment of software application upgrades to enterprise client computing environment. This includes comprehensive acceptance testing of packages as well as development of packages.

-Manage automated deployment of client security updates to enterprise. This includes (but is not limited to): desktop OS patches and hotfixes, cumulative service packs, and IE updates. Also, manage deployment and updates of desktop anti-virus solutions.

-Define, maintain and enforce IT infrastructure standards and collaborate with the Systems Engineering group and provide enhancements and modifications based upon business customers’ requirements.
5%

– Recommend procedures and standards to improve the level of support and interface with other members of IT, ensuring the rapid resolution of technical issues. This will be put into practice through creating, developing, and maintaining technical SOP’s, work instructions, policies and procedure documents.

-Develop, maintain, and recommend company Hardware and Software standards for the client.

-Serve as secondary / tertiary level of technical support for Help Desk staff.

-Generate customer facing documents. Desk guides, training aids, quick reference guides and other aids to make customers self sufficient.

-Maintain enterprise client imaging solutions. This includes (but is not limited to): GHOST server administration, image updates, testing and acceptance of new software, patches, as well as minor revisions.

-Manage desktop software licensing and desktop hardware inventory to ensure proper compliance and asset tracking
5%

Requirements:

-8-12 years of experience in 10+ years of experience in managing LAN/WAN environment based on Cisco platform.

-8-12 years of experience in 10+ years MS Windows server experience including Server 2003, 2008 and 2012 in both32 bit and 64 bit environment.

-8-12 years of experience in 10+ years of industry experience with networking technologies and security principals related to that.

-8-12 years of experience in 10+ years of experience in the following areas: Active Directory domain architecture and implementation; DHCP, WINS and DNS server administration; File and print server administration; Server Monitoring & Alerting; Security configuration and auditing for Windows.

-5-8 years of experience in 7+ years MS Exchange/email systems.

-BS degree in computer science, or equivalent experience. (4 years)

-Advanced knowledge of TCP/IP, routing protocols, LAN, WAN

-Good understanding of TCP/IP, routing protocols(BGP,EIGRP, OSPF), LAN, WAN and Transport Technologies including MPLS.

-4+ years virtualization experience using VMWare.

-Some experience in managing storage devices (SAN/NAS) preferably using EMC. Experience with real time data replication technology for Disaster recovery is preferred.

-MCSE and CCNP is preferred

Position Must Be Filled By April 15, 2016, So Apply Soon!

Position Summary:
This position requires both strong technical and interpersonal skills. The position will support the client’s enterprise client management product suite, including anti-virus, automated software deployment, imaging and scripting tools. Coordinate with members of the client’s Service Desk and Network Systems Engineering teams to ensure the efficient, timely delivery of software updates and patches. The individual must make independent and well executed judgments in researching, developing, and deploying effective solutions. They must ensure proposed changes to the enterprise client environment are fully tested and follow the client’s Change Management and Configuration Management policies and procedures, and serve as the centralized communication point for desktop anti-virus activities. The Network Administrator III will manage desktop hardware and software standards for the client.

Responsibilities:
-Solve incidents and requests or refer to other IT groups when necessary. Ensure that all interactions are documented via the electronic service request management software with clear technical descriptions of incidents / requests, work done to resolve, root causes and indicating all client interactions.

-Conduct detailed evaluations of new technology and educate IT staff on merits, weaknesses and recommendation on adoptability for the client.

– Manage automated deployment of software application upgrades to enterprise client computing environment. This includes comprehensive acceptance testing of packages as well as development of packages.

-Manage automated deployment of client security updates to enterprise. This includes (but is not limited to): desktop OS patches and hotfixes, cumulative service packs, and IE updates. Also, manage deployment and updates of desktop anti-virus solutions.

-Define, maintain and enforce IT infrastructure standards and collaborate with the Systems Engineering group and provide enhancements and modifications based upon business customers’ requirements.
5%

– Recommend procedures and standards to improve the level of support and interface with other members of IT, ensuring the rapid resolution of technical issues. This will be put into practice through creating, developing, and maintaining technical SOP’s, work instructions, policies and procedure documents.

-Develop, maintain, and recommend company Hardware and Software standards for the client.

-Serve as secondary / tertiary level of technical support for Help Desk staff.

-Generate customer facing documents. Desk guides, training aids, quick reference guides and other aids to make customers self sufficient.

-Maintain enterprise client imaging solutions. This includes (but is not limited to): GHOST server administration, image updates, testing and acceptance of new software, patches, as well as minor revisions.

-Manage desktop software licensing and desktop hardware inventory to ensure proper compliance and asset tracking
5%

Requirements:
-8-12 years of experience in 10+ years of experience in managing LAN/WAN environment based on Cisco platform.

-8-12 years of experience in 10+ years MS Windows server experience including Server 2003, 2008 and 2012 in both32 bit and 64 bit environment.

-8-12 years of experience in 10+ years of industry experience with networking technologies and security principals related to that.

-8-12 years of experience in 10+ years of experience in the following areas: Active Directory domain architecture and implementation; DHCP, WINS and DNS server administration; File and print server administration; Server Monitoring & Alerting; Security configuration and auditing for Windows.

-5-8 years of experience in 7+ years MS Exchange/email systems.

-BS degree in computer science, or equivalent experience. (4 years)

-Advanced knowledge of TCP/IP, routing protocols, LAN, WAN

-Good understanding of TCP/IP, routing protocols(BGP,EIGRP, OSPF), LAN, WAN and Transport Technologies including MPLS.

-4+ years virtualization experience using VMWare.

-Some experience in managing storage devices (SAN/NAS) preferably using EMC. Experience with real time data replication technology for Disaster recovery is preferred.

-MCSE and CCNP is preferred

Position Must Be Filled By April 15, 2016, So Apply Soon!

At Blue Harbors, we specialize in a few different areas of IT advisory service: GxP Validation Services, 21 CFR Part 11 Compliance, CA ePedigree Compliance, and Internal Audit Support. This position will be responsible for working closely with clients to develop an IT strategy that fully supports and validates their business objectives and infrastructure. They must develop findings, conclusions and recommendations and then present corresponding documentation to the client for consideration and decision making. They will authenticate various aspects of current processes and technology, and make recommendations to help the organization optimize efficiency. They will be in charge of overseeing the processes and making sure the project gets completed successfully and on time. This person will be the main point of contact for the project and final decision maker. They will manage key client relationships and ensure that the project is going successfully towards compliance and validation.

Responsibilities:

The responsibilities of employee will include, but not be limited to: performing initial audits on site to assess areas of risk and current good manufacturing practices, designing a plan of attack to go over areas of improvement, implementing and carrying out the project with other members of the team, following up the project with proper documentation and then presenting findings to client for review. They will be responsible for managing the end-to-end processes within the project. They must play an active role in the implementation and configuration of the system and produce quality client deliverables.

Qualifications:

Education: Bachelor’s degree in accounting, finance, business or a related field required; MBA preferred

Knowledge/Skills: Must be proficient is systems audit processing, IT governance, systems and infrastructure management, disaster recovery, business continuity and risk management. Must be familiar with internal audit Risk assessment processes and development of risk remediation strategies. Must have the ability to perform and interpret gap analysis and have strong project management skills including strategic planning and analysis, methodology, and scope. Must also possess project management experience and skills. Must possess excellent oral, written and interpersonal skills and be self-motivated.

Experience: Minimum 3 years of related audit or applicable business experience.

The Information Systems Auditor is responsible for evaluating and improving auditing processes within the company in the areas of risk management, control and governance, primarily as they relate to IT. They are responsible for implementing, designing, monitoring and reviewing performance of controls, software, security and operating systems. They also must monitor the project status of new systems development and perform disaster recovery testing. They must understand and apply industry standards and best practices in auditing practices and techniques.

Responsibilities:

The responsibilities of employee will include, but not be limited to: examining and verifying procedures, internal controls, operating systems and recorded data for the IT department, participating in the risk rating process and audit planning, and preparing audit draft reports and all audit workpaper sections. They must gather and preserve evidence using organized reporting techniques. They are responsible for completing audits of the information security and technology in a timely manner while analyzing systems logs and data to identify potential issues. They must lead evaluations of the IT infrastructure to ensure the effectiveness of controls, monitor efficiency, analyze and recommend upgrades for the system.

Qualifications:

Education: Bachelor’s degree in the field of Finance, IT, IS or related field required (Master’s degree a plus)

Knowledge/Skills: Must be proficient is information systems audit processing, IT governance, systems and infrastructure management, disaster recovery, business continuity and risk management. Must also possess project management experience and skills and working knowledge of LAN technology. Must possess excellent oral, written and interpersonal skills and be self-motivated. CISA/CISSA certification or equivalent required for this role.

Experience:  Minimum 3 years of experience in the field of IT auditing and system controls, with experience in risk identification, mitigation, and reporting being preferred.