Job Description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Job Title: Senior Computer Systems Validation Specialist

Location: Portsmouth, NH 03801

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: 1st Shift

Please Note: Applicants must be currently authorized to work full-time in the United States for any employer. This role does not offer visa sponsorship, now or in the future, and only W2 candidates will be considered for this position.

Summary


The Senior Computer Systems Validation Specialist / CSV Specialist Level 3 helps lead team members in assessing new and changing computerized systems to ensure compliance with company policies, procedures, and industry guidance. The role is responsible for risk assessing systems, reviewing change requests and test scripts, drafting protocols, initiating and reviewing GMP documentation revisions, and providing guidance to junior team members. The specialist also serves as the QA CSV representative for both small and large-scale projects.

Responsibilities

• Perform all aspects of QMS processes, including Change Control, Deviations, and CAPAs.
• Execute all responsibilities as CSV Project Lead for simple projects.
• Oversee and perform all CSV qualification activities for DeltaV and Syncade systems.
• Perform validation maintenance of computerized systems.
• Review and revise CSV SOPs.
• Review engineering documents, including P&IDs, SOPs, Specifications, and Submittals.
• Assist with audits and inspections.
• Perform other duties as assigned.
• Adhere to cGMP requirements during the manufacture of drug products.
• Notify responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects, and related actions.
• Follow job safety procedures and attend required health and safety training.
• Proactively promote workplace safety and promptly report actual and potential accidents and injuries.
• Comply with company and site safety policies.

Required Skills

• Bachelor's Degree in Computer Science, Software Engineering, or a related field.
• Experience in validating - DeltaV and Syncade + Spreadsheets and Sharepoint is required
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines related to Computer Systems Validation (CSV).
• Experience with QMS processes, including Change Control, Deviations, and CAPAs.
• Experience performing CSV qualification activities for DeltaV and Syncade systems.
• Experience with validation maintenance of computerized systems.
• Ability to review and revise CSV SOPs.
• Experience reviewing engineering documents such as P&IDs, SOPs, Specifications, and Submittals.
• Strong written and oral communication skills.
• Strong organizational and time management skills.

TekWissen Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity.

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