C&Q Engineer

Job Title: Commissioning & Qualification (C&Q) Engineer Location: North Carolina

Experience: 5 - 8 Years Employment Type: Contract (100% Onsite)

Position Overview

We’re looking for a skilled and detail-focused C&Q Engineer to support projects across several state-of-the-art pharmaceutical and biotech facilities in North Carolina. This role is hands-on and centered around commissioning, qualification, and validation of aseptic manufacturing systems, utilities, facilities, and lab equipment . You’ll play a critical role in ensuring systems are compliant, operational, and ready to support GMP manufacturing.

Key Responsibilities

Develop, review, and execute IQ/OQ/PQ protocols for process and lab equipment, packaging lines, utilities (clean & black), and automation systems.

Lead and support the full C&Q lifecycle for aseptic manufacturing, cleanroom systems, and packaging lines (e.g. blister machines, cartoners, serialization equipment).

Participate in FAT/SAT, system walkdowns , and installation/startup activities.

Perform risk assessments (FMEA, HAZOP) and integrate results into qualification strategies.

Ensure work complies with FDA, EMA , and site-specific regulatory requirements.

Collaborate with QA, Validation, Engineering, Manufacturing, and Vendors to deliver high-quality, compliant systems.

Manage and maintain validation documentation with a strong focus on data integrity.

Support deviation investigations, CAPAs, and change control processes .

Help prepare for internal and external audits and contribute to inspection readiness .

Track project milestones and deliverables, ensuring on-time execution .

Recommend and implement process improvements and C&Q best practices.

Required Qualifications

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related field).

5–8 years of experience in Commissioning & Qualification within pharmaceutical or biotech environments.

Strong working knowledge of cGMPs, validation principles, and regulatory guidelines .

Experience with aseptic systems , cleanroom qualifications, packaging lines, and critical utilities.

Skilled in C&Q documentation , change control, and validation lifecycle practices.

Strong problem-solving, analytical, and communication skills.

Ability to work effectively across multidisciplinary teams in a fast-paced, regulated environment .

Nice to Have

Familiarity with serialization and aggregation systems .

Experience with lab instrumentation validation .

Prior exposure to CAPA systems and audit processes.

This is a 100% onsite contract opportunity. If you thrive in regulated environments and enjoy bringing systems online the right way, we’d like to hear from you.