Job Title: Automation Documentation Specialist (Validation & Commissioning)
Location: Rahway, NJ or Wilmington, DE
Employment Type: Contract (W2)
Job Summary
Our pharmaceutical manufacturing client is seeking an Automation Documentation Specialist to support commissioning and validation activities for automated equipment used in new facility projects. The ideal candidate will have experience preparing and reviewing commissioning, qualification, and validation documentation in a GMP-regulated environment.
This role involves supporting equipment testing, reviewing vendor documentation, preparing qualification protocols, and coordinating with automation, engineering, quality, and vendor teams. Programming or automation engineering experience is not required.
Key Responsibilities
- Prepare and review requirements, specifications, commissioning and validation protocols, test scripts, and summary reports.
- Support commissioning and qualification of automated equipment, including OEM equipment and systems integrated with DeltaV.
- Witness equipment testing during installation and startup, document results, and verify compliance with approved requirements.
- Review vendor documentation for completeness, accuracy, and compliance with project specifications.
- Support the preparation, execution, and review of Installation and Operational Qualification (IOQ) protocols.
- Document deviations and support investigations, resolutions, and related change control activities.
- Coordinate with engineering, automation, quality, facilities, and vendor teams to complete validation deliverables.
- Maintain accurate, inspection-ready documentation in accordance with company SOPs and applicable GMP requirements.
Required Qualifications
- Experience preparing commissioning, qualification, or computer system validation documentation for automated equipment.
- Understanding of equipment qualification, requirements development, installation verification, operational testing, and final reporting.
- Experience in pharmaceutical, biotechnology, or GMP-regulated manufacturing environments.
- Familiarity with GAMP 5, 21 CFR Part 11, and EU Annex 11.
- Strong technical writing, documentation, organizational, and communication skills.
- Proficiency in Microsoft Word and Excel.
- Ability to collaborate effectively with cross-functional technical teams.
Preferred Qualifications
- Experience with Kneat validation software.
- Familiarity with Emerson DeltaV validation.
- Experience with single-use process equipment, including bioreactors, mixers, and filtration systems.
Pay Scale
Anticipated hourly pay range: $60/hr to $70/hr.
Benefits
Employees hired into this position are eligible for the following benefits, subject to the 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 paying 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