Contract Pharma Validation Specialist (Sterile/Aseptic)

Synerfac Inc; Whippany (NJ); Vor Ort; USD 51.000 - 73.000; Teilzeit

Zusammenfassung

Synerfac Inc. in Parsippany, NJ is seeking a Validation Specialist for a contract role at a pharmaceutical contract development and manufacturing organization.

The role involves executing validation activities across sterile and aseptic environments, supporting facilities, equipment, and laboratory systems. You will ensure compliance with industry standards and regulatory requirements (FDA, EMA, Annex 1), write reports, participate in audits as SME, and collaborate with QA, Engineering,

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, or related STEM required.
• 3+ years of validation experience in pharma/biopharma, sterile/aseptic focus.
• Strong knowledge of cGMP, FDA guidance, Annex 1, lifecycle validation.

Aufgaben

• Develop and execute IQ/OQ/PQ validation protocols for clean utilities, autoclaves, isolators, sterilizers, lab instruments, fillers, and temp control units.
• Conduct risk assessments to identify critical process parameters and validation needs.
• Support projects including new equipment installation, capital expansions, and legacy re-qualification.
• Analyze data, write validation reports, and secure approvals and closure of docs.
• Review protocols, SOPs, change controls, CAPAs, and technical reports.
• Act as SME during audits (regulatory, client, internal) and support defense of validation topics.
• Collaborate with QA, Engineering, Operations, and external vendors to ensure compliant validation execution.
• Ensure alignment with GAMP5, ISPE Baseline Guides, FDA Process Validation Guidance, and EU Annex 1.

Kenntnisse

Validation

cGMP

Communication

MS Office

Ausbildung

Bachelor's degree in Engineering

Tools

Validation software

Jobbeschreibung

Synerfac Inc. in Parsippany, NJ is seeking a Validation Specialist for a contract role at a pharmaceutical contract development and manufacturing organization.

The role involves executing validation activities across sterile and aseptic environments, supporting facilities, equipment, and laboratory systems. You will ensure compliance with industry standards and regulatory requirements (FDA, EMA, Annex 1), write reports, participate in audits as SME, and collaborate with QA, Engineering,