Principal Commissioning/Validation Engineer III

Title: Principal Commissioning/Validation Engineer III

Location: Swiftwater, PA

Duration: 9 Months+ Possible Extension

Function: Quality Systems / Continuous Improvement

Focus: Formulation & Filling

Pay Range: $75-$80/hr

Manager Notes:

Must Have:

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• Bachelor’s degree and 3–5 years of relevant experience
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• Strong experience with deviations, Quality Systems, continuous improvement, and regulated GMP pharmaceutical or biotech manufacturing environments.
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• Experience with eBR, Opstrakker, MES, or similar digital manufacturing systems.
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• Experience with comparable Quality systems such as Qualipso/Veeva is acceptable.
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Nice to Have Experience/ Skills:

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• Previous biotech and/or pharmaceutical manufacturing experience strongly preferred.
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• Familiarity with OEE (Overall Equipment Effectiveness) and using performance metrics to identify equipment/process improvement opportunities.
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• Background in formulation, filling, lyophilization (freeze-drying), and/or inspection is a plus.
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Position Summary:

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• The Quality Systems / Continuous Improvement Contractor will provide dedicated support to pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling.
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• This position will partner with Quality, Operations, Engineering, MSAT, Sterility Assurance, and other cross-functional teams to drive CAPA, Change Control, quality investigations, root cause analysis, and continuous improvement initiatives while maintaining compliance with cGMP and regulatory requirements.
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Key Responsibilities:

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• Serve as the CAPA and Change Control point of contact supporting Formulation and Filling improvement initiatives.
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• Independently manage CAPA and Change Control actions, ensuring accurate documentation and timely closure.
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• Lead quality investigations, troubleshooting, root cause analysis, product impact assessments, and corrective/preventive actions.
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• Partner with SMEs and cross-functional stakeholders to resolve manufacturing and quality issues.
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• Provide technical support for component qualification, Overall Equipment Effectiveness (OEE), electronic Batch Records (eBR), Opstrakker, and factory improvement initiatives.
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• Support continuous improvement efforts utilizing Lean Manufacturing, Six Sigma, and +QDCI Visual Management principles.
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• Monitor and communicate key performance metrics and identify opportunities for process improvement.
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• Author and maintain high-quality protocols, technical reports, investigations, CAPAs, and Change Controls.
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• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
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• Support regulatory inspections and audits as required.
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Required QualificationsMinimum Education:

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• Bachelor’s degree
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• Minimum 3–5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
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• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
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• Experience with formulation, filling, lyophilization, and/or inspection processes.
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• Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.
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• Knowledge of Lean Manufacturing and Six Sigma methodologies.
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• Strong technical writing, project management, problem-solving, and cross-functional communication skills.
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• Proficiency in Microsoft Excel, Word, and PowerPoint.
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• Experience with iShift, Qualipso, eBR, and Opstrakker preferred.
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