Automation Documentation Specialist

Job Description

Job Title: Automation Documentation Specialist (Validation & Commissioning)

Company: Novozen Healthcare LLC

Location: 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 W2

Job Responsibilities

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• Prepare and review requirements, specifications, commissioning and validation protocols, test scripts, and summary reports.
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• Support the commissioning and qualification of automated equipment, including OEM equipment and systems integrated with DeltaV.
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• Witness equipment testing during installation and startup, document test results, and verify alignment with approved requirements.
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• Review vendor documentation for completeness, accuracy, and compliance with project requirements.
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• Support the preparation, execution, and review of Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
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• Document deviations and support their resolution, including related change control activities.
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• Coordinate with engineering, automation, quality, facilities, and vendor teams to complete documentation and validation deliverables.
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• Maintain accurate, inspection-ready records in accordance with company SOPs and applicable Good Manufacturing Practice (GMP) requirements.
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Required Qualifications

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• Experience preparing commissioning, qualification, or Computer System Validation (CSV) documentation for automated equipment.
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• Understanding of equipment validation processes, including requirements development, installation verification, operational testing, and final reporting.
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• Experience in a pharmaceutical, biotechnology, or GMP manufacturing environment.
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• Familiarity with applicable validation guidance and regulatory requirements, including GAMP 5, 21 CFR Part 11, and EU Annex 11.
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• Strong documentation, organizational, and communication skills.
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• Proficiency in Microsoft Word and Excel.
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• Ability to collaborate effectively with engineering, automation, quality, facilities, and vendor teams.
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• Programming or controls design experience is not required.
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Preferred Qualifications

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• Experience with Kneat validation software.
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• Familiarity with DeltaV validation.
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• Experience with single-use process equipment, such as bioreactors, mixers, and filtration systems.
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Pay Scale

$60 - $65/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.