Senior Validation Specialist

Synerfac Inc; Whippany (NJ); On-site; USD 51,000 - 73,000; Part time

Job summary

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,

Qualifications

• 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.

Responsibilities

• 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.

Skills

Validation

cGMP

Communication

MS Office

Education

Bachelor's degree in Engineering

Tools

Validation software

Job description

Job Details

Location: Whippany, NJ

Branch: Parsippany

Category: Scientific

Job Type: Temporary

Salary: $45.00 - $45.00

Phone: [phone]

Job ID#: 123305

Position Summary

A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market.

The Validation Specialist will execute validation activities across sterile and aseptic manufacturing environments, supporting facilities, utilities, equipment, laboratory systems, and manufacturing processes. This individual will ensure that all validation activities meet current industry standards, regulatory requirements (FDA, EMA, Annex 1), and internal quality expectations. The ideal candidate will demonstrate technical expertise and collaboration within cross-functional teams.

Essential Functions

• Develop and execute validation protocols (IQ/OQ/PQ) for clean utilities, autoclaves, isolators, sterilizers (VHP & steam), laboratory instruments, fillers, and controlled temperature units.
• Conduct risk assessments to determine critical process parameters and validation requirements.
• Participate in validation projects, including new manufacturing equipment installation, capital expansion, and re-qualification of legacy systems.
• Analyze data, write validation reports, and ensure timely approval and closure of validation documentation.
• Review protocols, SOPs, change controls, CAPAs, and technical reports.
• Act as SME during audits (regulatory, client, internal) and support the preparation and defense of validation-related topics.
• Collaborate with Quality Assurance, Engineering, Operations, and external vendors to ensure compliant and efficient validation execution.
• Ensure alignment with GAMP5, ISPE Baseline Guides, FDA Process Validation Guidance, and EU Annex 1.
• Stay updated on industry trends and regulatory expectations; propose improvements to the validation program accordingly.

$45.00/hr

Required Qualifications

• Bachelor"s degree in Engineering, Life Sciences, or related STEM discipline.
• Minimum 3 years of validation experience in the pharmaceutical or biopharmaceutical industry, specifically in sterile/aseptic manufacturing.
• Experience with validation of:
  • Sterilization processes (Steam & VHP)
  • Sterile filtration & aseptic process validation (APV/PPQ)
  • ISO 5 isolators, cleanrooms, utilities
• In-depth knowledge of cGMP regulations, Annex 1, FDA Guidance, and validation of lifecycle requirements.
• Excellent communication skills to articulate technical information clearly in a GMP environment.
• Proficient in Microsoft Office (Word, Excel, Outlook); experience with validation tools/software preferred.
• Ability to perform multiple projects simultaneously and meet tight deadlines in a fast-paced environment.
• Available to work off-hours and weekends to support critical manufacturing and validation timelines.

Preferred Qualifications

• Bachelor"s degree or higher in a relevant field.
• Experience with Cleaning Validation and Computer System Validation (CSV).
• Familiarity with capital project validation and facility buildouts.
• Prior client-facing experience supporting tech transfers or product launches is highly desirable.