Sr. CQV Engineer

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.