Validation Documentation Specialist

Job Title: Validation Documentation Specialist

Company: Novozen Healthcare LLC.

Location: Rahway, NJ or Wilmington, DE (Hybrid – 3–5 days onsite per week)

Employment Type: 12-Month Contract

Job Responsibilities:

• Prepare and review commissioning and validation documents, protocols, test scripts, and reports.
• Support the commissioning and qualification of automated equipment, including OEM systems and DeltaV-integrated equipment.
• Witness equipment testing, record results, and verify compliance with approved requirements.
• Review vendor documents for accuracy and completeness.
• Support the preparation and execution of Installation and Operational Qualification (IOQ) protocols.
• Document deviations and support change control activities.
• Coordinate with engineering, automation, quality, facilities, and vendor teams.
• Maintain accurate documentation in compliance with GMP requirements and company SOPs.

Required Qualifications:

• Experience preparing commissioning, qualification, or validation documentation for automated equipment.
• Understanding of equipment qualification, testing, and validation processes.
• Experience in pharmaceutical, biotechnology, or GMP manufacturing environments.
• Familiarity with GAMP 5, 21 CFR Part 11, and Annex 11.
• Programming or controls design experience is not required.

Pay Scale

• Anticipated hourly pay range: $40/hr to $48/hr (W2), depending on experience (DOE).

Benefits

• Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of their insurance premiums.

• Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

• Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.