Senior Validation Specialist

Location:

Whippany, NJ

Branch:
Parsippany

Category:
Scientific

Job Type: Temporary

Salary: $45.00 - $45.00

Phone:

Job #: 123305

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.

• 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

• 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, clean rooms, 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.

• 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.