Job Description
Principal Commissioning and Validation Engineer
Location: Swiftwater, PA 18370
Duration : 9+ Months
Function: Quality Systems / Continuous Improvement
Focus: Formulation & Filling
Summary
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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.
- 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.
- 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.
- 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.
- Previous biotech and/or pharmaceutical manufacturing experience strongly
- 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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Numbers & Facts
| Location | Swiftwater, PA |
| Industry | Staffing/Employment Agencies |
| Salary | $70–$74 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
About Company
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!
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