Automation Documentation Specialist

Job Title: Automation Documentation Specialist (Validation & Commissioning)
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Company: Novozen Healthcare LLCLocation: Rahway, NJ (Hybrid – 3–5 days onsite per week) OR Wilmington, DE (Hybrid – 3–5 days onsite per week)Employment Type: Contract – 12 Months+ (Extensions Possible)Pay Scale: $60 - $65/hr on W2Job ResponsibilitiesPrepare and review requirements, specifications, commissioning and validation protocols, test scripts, and summary reports.Support the commissioning and qualification of automated equipment, including OEM equipment and systems integrated with DeltaV.Witness equipment testing during installation and startup, document test results, and verify alignment with approved requirements.Review vendor documentation for completeness, accuracy, and compliance with project requirements.Support the preparation, execution, and review of Installation Qualification (IQ) and Operational Qualification (OQ) protocols.Document deviations and support their resolution, including related change control activities.Coordinate with engineering, automation, quality, facilities, and vendor teams to complete documentation and validation deliverables.Maintain accurate, inspection-ready records in accordance with company SOPs and applicable Good Manufacturing Practice (GMP) requirements.Required QualificationsExperience preparing commissioning, qualification, or Computer System Validation (CSV) documentation for automated equipment.Understanding of equipment validation processes, including requirements development, installation verification, operational testing, and final reporting.Experience in a pharmaceutical, biotechnology, or GMP manufacturing environment.Familiarity with applicable validation guidance and regulatory requirements, including GAMP 5, 21 CFR Part 11, and EU Annex 11.Strong documentation, organizational, and communication skills.Proficiency in Microsoft Word and Excel.Ability to collaborate effectively with engineering, automation, quality, facilities, and vendor teams.Programming or controls design experience is not required.Preferred QualificationsExperience with Kneat validation software.Familiarity with DeltaV validation.Experience with single-use process equipment, such as bioreactors, mixers, and filtration systems.Pay Scale$60 - $65/hr on W2BenefitsEmployees 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. xzbcwsv Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.