| Location | NULL, NJ |
| Salary | $45–$56 |
Job Title: Automation Documentation Specialist (Validation & Commissioning)
Location: New Jersey (Hybrid)
Employment Type: Contract W2
Job 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 alignment with approved requirements.
Review vendor documentation for completeness, accuracy, and compliance with project requirements.
Support preparation, execution, and review of Installation and Operational Qualification (IOQ) protocols.
Document deviations and support resolution and related change control activities.
Coordinate with Engineering, Automation, Quality, Facilities, and vendors to complete validation deliverables.
Maintain accurate, inspection-ready records 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 requirements development, installation verification, operational testing, and final validation reporting.
Experience in pharmaceutical, biotechnology, or GMP manufacturing environments.
Familiarity with GAMP 5, 21 CFR Part 11, and EU Annex 11.
Strong documentation, organizational, communication, and cross-functional collaboration skills.
Proficiency with Microsoft Word and Excel.
Kneat experience preferred.
Familiarity with DeltaV validation and single-use process equipment, including bioreactors, mixers, and filtration systems, preferred.
Programming, controls design, or automation engineering experience is not required.
Pay Scale:
Anticipated hourly pay range: $45/hr to $56/hr on W2.
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.