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Remote Senior CSV Consultant

Non-Headquarters

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

REMOTE SENIOR CSV CONSULTANT
(ENTERPRISE COMPUTER SYSTEMS)

We have a special project for a Computer System Validation Engineer to support our client globally. The ideal candidate will have experience in the validation of computer systems within biopharmaceutical environments. This is a great opportunity to validate enterprise computer systems. The remote senior CSV consultant will work with global representatives from the company in Ohio, New Jersey, California, and Europe, remotely. Part-time, 6 months+.

The candidate should have expertise in SDLC documentation, (verification) testing, data compliance, qualification and validation of computer systems. Systems include the following:

      1. Microsoft Active Directory (Windows Server 2016/2019) hosted in AWS Cloud on EC2 Windows Servers.
      2. Microsoft Endpoint Configuration Manager Current Branch (version 2203) hosted in AWS Cloud on EC2 Windows Servers & SQL Server.
      3. McAfee ePolicy Orchestrator (ePO – version 5.3 and 5.10) hosted in AWS Cloud on EC2 Windows Servers, AWS RDS & S3 buckets.
      4. IPSEC tunnel – technical configuration so that the communication between the AWS Cloud and the shop floor network in the MMD sites can be established.

The Computer System Validation Engineer will work in the Quality group and collaborate across functions (e.g. quality, IT, and vendors) and assist lead validation engineers and the head of validation in developing practical and thorough solutions to problems, and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer.

This objective will be accomplished by executing the following activities: Coordinate and execute commissioning and qualification of equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.

RESPONSIBILITIES

  • Development and execution of qualification and validation documentation according to GAMP 5 guidance for Computer Systems.
    • Documentation includes, but not limited to: Risk Assessments, Validation Plans, Design Specifications, User Requirements, Functional Requirements, IQ/OQ/PQ Protocols, Requirements Traceability Matrices, and Summary Reports.
  • Validation of computer systems, such as servers, network devices, and related peripherals.
  • Creation of new and updates to existing IT documentation, including:
    • OT Baseline
    • OT Identity Management for Shop Floor Network
    • OT Security Baseline
    • OT Security Supplementary Guidance
  • Development of SDLC documentation, including:
    • Quality Assurance Plan (QAP)
    • IT Risk Assessments
    • Requirements Specification
    • Configuration Specifications
    • Test Protocols/UAT
    • Requirements Traceability Matrix (RTM)
    • Disaster Recovery Plan
    • Quality Assurance Summary Report (QASR)
    • SOPs and Work instructions

SKILLS AND EXPERIENCE

  • Experience qualifying computer systems within a life sciences environment.
  • Solid knowledge of qualification/validation principles and their practical applications.
  • Direct experience developing and executing validation protocols.
  • Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
  • A team player with excellent verbal, written and interpersonal communication skills

This is a great opportunity to expand your experience with validation in biopharma. Apply today!

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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