Piper Companies is hiring a skilled Lead CQV Engineer for an onsite, contract position based out of Lebanon, IN. The Lead CQV Engineer will be responsible for lead commissioning, qualification, and validation (CQV) efforts for a greenfield API manufacturing project, focusing on downstream purification systems and critical utilities.
Responsibilities of the Lead CQV Engineer:
- Lead CQV activities for a greenfield API manufacturing facility, focusing on downstream purification systems and associated skids.
- Oversee commissioning and qualification of utility systems including WFI, glycol, solvents, and process gases.
- Collaborate with cross-functional teams to ensure timely execution of project milestones and compliance with regulatory standards.
- Develop and review CQV documentation, including protocols, reports, and risk assessments.
- Provide technical leadership and mentorship to junior engineers and support staff throughout the project lifecycle.
Qualifications for the Lead CQV Engineer:
- 7–8 years of experience in API process systems and utility CQV, with a strong background in downstream/purification technologies.
- Proven track record of leading large-scale capital projects, preferably in greenfield environments.
- Bachelor’s degree in engineering or a related technical discipline; advanced degree or certifications in CQV or GMP compliance are a plus.
- In-depth knowledge of industry standards, regulatory requirements, and best practices in pharmaceutical CQV.
- Strong communication, organizational, and leadership skills, with the ability to work effectively in a team-oriented environment.
Compensation for the Lead CQV Engineer:
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Salary: $124,000-$130,000 USD/year
- Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
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