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Principal Quality Assurance CSV Specialist

Devens, MA

Posted: 01/24/2023 Job Number: 22935476

Job Description

Hybrid Work Schedule: 50% Onsite

Top Skills Required:
  • Computer Systems Validation.
  • Proactive, self-motivated, and needing minimum supervision.
  • Deviations and investigations.
  • MES systems preferred; Delta V will work w/coding experience.

Required Skills:
  • Knowledge of science generally attained through studies resulting in a bachelor's degree in a scientific or engineering discipline.
  • A minimum of 6 years' experience in an environment governed by cGMPs, in a computer systems validation or quality assurance validation role overseeing electronic equipment and computerized systems validation.
  • Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
  • Firm understanding of quality systems.
  • Proficiency in the use of computers and software applications including electronic validation documentation systems (such as ValGenesis and ALM).
  • Demonstrated interpersonal, communication, and motivation skills.
  • Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
  • Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is required.
  • Effective written and verbal communication skills Development Value.
  • Interface with many functional areas including Manufacturing Science and Technology, Digital Plant, Manufacturing, Validation.
  • Knowledge of applicable business systems including: Veeva Vault is desirable.

Project Description:
  • Highly experienced computer systems validation professional with strong compliance mindset.
  • Role will support the validation of computerized systems, including, but not limited to, process automation systems (DeltaV), manufacturing execution systems (MES), databases, Analytical Equipment, and IT infrastructure.
  • Oversee the qualification of process automation systems, Analytical and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
  • Interface with MS&T, Validation, and end user groups as a Quality subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, software testing, system administration, data management, and risk-management.
  • Support the implementation and maintenance of Computer System changes, aligning with site compliance policies and procedures.
  • Review and approve qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.
  • Ensure that all regulatory and cGMPs compliance items related to validation are satisfied.
  • Review and approve exceptions associated with the qualification and participate in resulting investigations and correction / corrective action planning.
  • Verify compliance with applicable Policies, Guidelines and Directives and ensures consistency with site procedures and/or specifications.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.Com


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Cheryl Ambrose

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