ATL01-111025 Packaging Validation EngineerPA
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Job Location:
Allentown, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group Inc. (V&EG) is a leading technical services provider specializing in high-quality Commissioning & Qualification Validation Compliance Quality Assurance and Engineering services for the Biotechnology Pharmaceutical Advanced Therapies Medical Device and Chemical (API) industries.
We are seeking a talented dedicated individual committed to working under the highest ethical standards for the following position:
- Packaging Validation Engineer
Position Overview:
We are seeking a Validation Engineer with strong experience in pharmaceutical packaging systems and GMP manufacturing environments. The selected candidate will focus on the qualification of packaging equipment and processes ensuring compliance with regulatory requirements and company standards. This role will support validation packaging engineering and continuous improvement initiatives to maintain and enhance product quality and operational efficiency.
Responsibilities:
- Lead and execute equipment and process qualification activities (IQ/OQ/PQ) for primary and secondary packaging systems including serialization/aggregation systems.
- Prepare and execute validation protocols and reports ensuring adherence to cGMP FDA and EU regulatory expectations.
- Support packaging validation life-cycle documentation including URS FRS DS FAT SAT risk assessments and traceability matrices.
- Participate in deviations CAPAs and change control processes related to packaging systems and associated utilities.
- Collaborate with Production Engineering and Quality to troubleshoot equipment and process issues during qualification and routine operations.
- Support technology transfer activities and new product introductions related to packaging operations.
- Coordinate multiple project tasks from inception to completion applying sound project management and documentation practices.
- Ensure compliance with GMPs Good Engineering Practices (GEP) and company standards and procedures.
Requirements / Skills:
- Bachelor of Science degree in Engineering (Mechanical Packaging Chemical or related discipline) or in Natural Sciences.
- 5 years of experience in pharmaceutical medical device or biotech environments with a focus on equipment qualification and packaging systems.
- Solid knowledge of primary and secondary packaging equipment and materials (vials syringes bottles labels cartons etc.).
- Strong understanding of validation principles including IQ/OQ/PQ risk assessments and validation life-cycle documentation.
- Experience developing and executing technical documents (URS FRS DS FAT/SAT protocols and reports).
- Familiarity with serialization and aggregation systems (Optel) preferred.
- Excellent analytical organizational and technical writing skills.
- Strong communication skills (written and verbal) with ability to interface effectively with cross-functional teams and clients.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
