CQV Engineer

Piper Companies is seeking a CQV Engineer to join a leading organization focused on ensuring operational readiness for biotech innovators. This role requires strong expertise in aseptic fill lines and the ability to work independently in a fast-paced environment.

Key Responsibilities

• Develop and maintain user requirement specifications, traceability matrices, and design documentation.
• Author IOQ protocols and assist with PQ planning and execution.
• Conduct ongoing assessments and support integration of test references.
• Collaborate with vendors and cross-functional teams, including QA and process engineering.
• Lead commissioning and qualification activities for aseptic fill lines and associated equipment.

Qualifications

• Experience:
  • 5+ years in pharmaceutical manufacturing.
  • 2+ years working with aseptic fill lines.
• Strong knowledge of manufacturing equipment (e.g., tanks, autoclaves).
• Proven ability to generate and execute protocols with clear documentation.
• Bachelor’s degree in engineering, chemistry, or a related discipline.

Compensation & Benefits

• Salary: $114,000–$124,000 annually.
• Comprehensive benefits package including medical, dental, vision, 401(k), and sick leave (as required by law).

Keywords: CQV, aseptic fill lines, IQ/OQ/PQ, GMP, protocol development, commissioning, qualification, validation, cleanroom, vendor coordination, pharmaceutical manufacturing, equipment validation.

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