Automation Documentation Specialist (Validation & Commissioning)

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.