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Sr. CQV Engineer

Sr. CQV Engineer

Stark Pharma Solutions IncIN, United States
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Job Title : Sr. CQV Engineer

Location : Indiana

Experience : 5 10 years

Job Overview :

We are seeking an experienced Senior HVAC / Utilities / CQV Engineer with extensive hands-on experience in commercial HVAC systems. Candidates from semiconductor or related industries may also be considered. This role requires a strong understanding of both cGMP and non-GMP documentation, with the ability to manage boundaries where non-GMP processes tie into GMP requirements.

Responsibilities :

Oversee design, commissioning, qualification, and validation of HVAC and utilities systems.

Manage multiple vendors and coordinate work schedules to ensure project timelines are met.

Review, prepare, and manage documentation in compliance with cGMP and non-GMP requirements.

Multi-task and prioritize workloads effectively in a fast-paced, on-site environment.

Collaborate with the C&Q team to ensure smooth project execution and compliance.

Handle occasional extended hours and weekend work as required.

Requirements :

5 10 years of experience in HVAC, utilities, or CQV engineering, with strong industry knowledge.

Extensive experience in pharmaceutical environments preferred; semiconductor or similar industries acceptable.

Strong knowledge of cGMP and non-GMP systems and documentation practices.

Proven ability to manage multiple vendors and coordinate complex schedules.

Excellent communication, negotiation, and organizational skills.

Ability to work 100% on-site with flexibility for extended hours.

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