Automation Documentation Specialist

Job Title: Automation Documentation Specialist (Validation & Commissioning)

Location: NJ or DE (Hybrid 3 5 days onsite per week)

Employment Type: Contract

Duration: 12 months + extensions

Job Description:

Our pharmaceutical manufacturing client is seeking an experienced Automation Documentation Specialist to support the commissioning and validation of automated equipment for new facility projects. The ideal candidate will have hands-on experience preparing and reviewing validation documentation, executing equipment testing, and supporting commissioning and qualification activities in a regulated pharmaceutical or biotechnology manufacturing environment.

The role involves collaborating with automation, engineering, quality, facilities, and vendor teams to ensure equipment meets approved requirements and all validation deliverables are completed accurately and on schedule. Experience with OEM equipment, DeltaV-integrated systems, and GMP documentation is highly desirable. Programming and automation controls design experience are not required.

Key Responsibilities:

• Prepare and review user requirements, equipment specifications, commissioning protocols, validation protocols, test scripts, and summary reports.

• Support commissioning, qualification, and validation 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 accuracy, completeness, and alignment with project requirements.

• Support the preparation, execution, and review of Installation and Operational Qualification (IOQ) protocols.

• Document deviations, support investigations and resolutions, and assist with change control activities.

• Coordinate with engineering, automation, quality, facilities, and vendors to complete project documentation and validation deliverables.

• Maintain accurate, traceable, and inspection-ready records in accordance with company SOPs and applicable GMP requirements.

Requirements:

• Experience preparing commissioning, qualification, or computer system validation documentation for automated equipment.

• Understanding of equipment validation processes, including requirements development, installation verification, operational testing, and final reporting.

• Experience working in pharmaceutical, biotechnology, or other GMP-regulated manufacturing environments.

• Familiarity with GAMP 5, 21 CFR Part 11, and EU Annex 11 requirements.

• Experience developing, reviewing, or executing validation protocols, test scripts, and technical reports.

• Strong documentation, organizational, communication, and problem-solving skills.

• Proficiency in Microsoft Word and Excel.

• Ability to collaborate effectively with technical teams and equipment vendors.

Preferred Qualifications:

• Experience with Kneat validation software.

• Familiarity with Emerson DeltaV validation and integrated automated equipment.

• Experience with single-use process equipment, including bioreactors, mixers, and filtration systems.

• Exposure to commissioning, startup, equipment qualification, deviation management, and change control activities.

Work Arrangement: Candidates must be able to work onsite 3 5 days per week at either Rahway, NJ, or Wilmington, DE.

Important Note: This position focuses on validation documentation, commissioning, and qualification support. Programming and controls design experience are not required.

Pay Scale:{$50/hr}on W2
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 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 is provided other than that required by applicable state and local laws.