Validation Engineer Pharma Onsite Warren Nj

Validation Engineer Pharma (Onsite Warren, NJ)

You will also contribute to the completion of milestones associated with facility, utility, and equipment qualification.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Warren, NJ.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities:

• Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
• Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures
• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
• Familiarity with 21 CFR Part 11 compliance.
• Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
• Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
• Preferred experience executing temperature/humidity mapping qualifications for controlled storage areas, controlled temperature units (incubators, refrigerators, freezers), and cryogenic storage systems
• Preferred experience executing airflow visualization qualifications (smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas
• Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
• Strong computer skills in Microsoft Office Suite Word, Excel, Power Point, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
• Manage projects of limited scope and complexity.
• Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
• Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.

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