Senior Computer Systems Validation Specialist

MilliporeSigma; Rockville (MD); In loco; USD 81.000 - 121.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Paid time off (PTO)

Retirement contributions

Descrizione del lavoro

MilliporeSigma is seeking a Senior Quality Specialist – Computer Systems Validation to audit and improve validation documentation within the Quality Assurance team. You will ensure compliance with 21 CFR Part 11 and related regulatory standards while collaborating with global cross-functional teams to achieve on-time system go-lives and continuous improvement initiatives.

The role requires a Bachelor's degree and 6+ years' experience in pharma/biotech validation, with strong writing skills and

Competenze

• Bachelor’s degree required in any discipline.
• 6+ years' experience in validation or QA validation in pharma/biotech.
• Strong technical writing and regulatory documentation skills.

Mansioni

• Review and audit computerized system validation deliverables per 21 CFR Part 11 and Annex 11.
• Review validation docs including requirements, validation plans, IQ/OQ/PQ, risk assessments, tests, and trace matrices.
• Collaborate with global teams to meet go-live and enhancement targets.
• Lead continuous improvement for the CSV program and support regulatory inspections.

Conoscenze

Technical writing

Regulatory compliance knowledge

Formazione

Bachelor's Degree

Descrizione del lavoro

MilliporeSigma is seeking a Senior Quality Specialist – Computer Systems Validation to audit and improve validation documentation within the Quality Assurance team. You will ensure compliance with 21 CFR Part 11 and related regulatory standards while collaborating with global cross-functional teams to achieve on-time system go-lives and continuous improvement initiatives.

The role requires a Bachelor's degree and 6+ years' experience in pharma/biotech validation, with strong writing skills and