Manufacturing/Packaging Engineer---W2

Job Title: Manufacturing/Packaging Engineer

Location: Minnesota
Duration: 12+ months Contract

Key Responsibilities:

• Lead the recharacterization and verification of pharmaceutical packaging equipment during the transition from Yvec to foil materials.
• Develop and execute process characterization studies, design of experiments (DOE), and heat-sealing parameter optimization.
• Perform equipment setup, testing, and qualification (IQ/OQ/PQ) in compliance with cGMP and FDA standards.
• Collaborate cross-functionally with Quality, Validation, Manufacturing, and Packaging teams to ensure smooth transition and product integrity.
• Update or create required documentation — protocols, reports, batch records, and work instructions.
• Troubleshoot packaging equipment and process issues to improve performance and consistency.
• Analyze process data and recommend improvements to ensure process robustness and reproducibility.
• Ensure all activities adhere to Good Manufacturing Practices (GMP) and safety standards.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Packaging Engineering, or a related technical field.
• 5+ years of experience in pharmaceutical or medical device manufacturing and packaging environments.
• Hands-on experience with heat sealing processes, form-fill-seal, and foil-based packaging materials.
• Proven background in process characterization, validation, and equipment qualification (IQ/OQ/PQ).
• Strong understanding of cGMP, FDA, and ISO 13485 regulatory requirements.
• Excellent analytical, documentation, and problem-solving skills.
• Strong communication and cross-functional collaboration abilities.

Preferred Qualifications:

• Experience with material transition projects (e.g., polymer to foil).
• Familiarity with packaging machinery such as blister or pouch sealers.
• Knowledge of statistical analysis tools (Minitab, JMP, etc.) for process validation.

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• If you’re open to new opportunities, please share your updated resume with me at:

Email: chandrashekar.s@unitedpharma.us

Contact: 551-300-0486

Job Type: Contract

Pay: $35.00 - $45.00 per hour

Work Location: In person