Piper Companies
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Business Consulting and Services
#J-18808-Ljbffr
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Business Consulting and Services
#J-18808-Ljbffr