Principal Commissioning and Validation Engineer

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. Provide technical support for component qualification, Overall Equipment Effectiveness (OEE), electronic Batch Records (eBR), Opstrakker, and factory improvement initiatives.

Principal Commissioning and Validation Engineer
Location: Swiftwater, PA 18370
Duration : 9+ Months

Function: Quality Systems / Continuous Improvement
Focus: Formulation & Filling

Summary

• The Quality Systems / Continuous Improvement Contractor will provide dedicated support to pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling. 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.

Key Responsibilities

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

Required Qualifications

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

Must Have:

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

Nice to Have Experience/ Skills:

• Previous biotech and/or pharmaceutical manufacturing experience strongly 

Preferred:

• Familiarity with OEE (Overall Equipment Effectiveness) and using performance metrics to identify equipment/process improvement opportunities.
• Background in formulation, filling, lyophilization (freeze-drying), and/or inspection is a plus

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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.