What are the responsibilities and job description for the Automation Documentation Specialist position at Novozen Healthcare LLC?
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
- Prepare 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 Qualifications
- Experience 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 Qualifications
- Experience 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 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.
Salary : $60 - $65