Principal Consultant – Commissioning & Qualification (C&Q) Position Available In Wake, North Carolina

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Position Overview As a Principal Consultant – Commissioning & Qualification (C&Q) , you will spearhead PQE Group’s US operations with a focus on Commissioning & Qualification (C&Q), for pharmaceutical, biotechnology, and medical device industries. With your expertise, you will ensure compliance with FDA cGMP (21 CFR 210-211, Part 11), EU Annex 11, ALCOA+, and GAMP 5, while driving strategic growth and operational excellence across US subsidiaries.

Location:

Raleigh, North Carolina, US. 1.

Strategic Leadership & Governance:

Oversee C&Q and validation programs for US offices, aligning with corporate objectives and local market practices. Serve as liaison between PQE’s Executive Board and US teams, ensuring seamless communication of quality, performance metrics, and risk mitigation strategies. Lead business development to expand PQE’s US footprint in C&Q and validation services. 2. Technical Excellence in

C&Q & Validation:

Commissioning & Qualification:

o Develop and execute Validation Master Plans (VMPs), IQ/OQ/PQ protocols, and risk assessments (ASTM

E2500, FMEA

) for: §

Facilities:

HVAC, clean utilities (WFI, pure steam), warehousing, sterile processing areas. §

Equipment:

Bioreactors, autoclaves, lyophilizers, packaging lines, and lab systems (HPLC, SCADA). o Lead FAT/SAT execution, P&ID reviews, and technical drawing verification.

CSV & Data Integrity:

o Remediate gaps in CSV lifecycle documentation (URS, FS, DS, TM) for ERP, MES, and lab systems (e.g., Empower 3, TrackWise). o Conduct Data Integrity Audits (ALCOA+) and implement CAPA plans for FDA/EU compliance. 3.

Compliance & Auditing:

Perform mock FDA/EU audits, supplier qualifications, and remediation for warning letters. Strengthen Quality Systems through SOP development, preventive maintenance plans, and calibration strategies. 4.

Project & Team Management:

Lead end-to-end C&Q and validation projects with a focus on timely delivery, budget adherence, and risk mitigation. Utilize agile and waterfall methodologies as appropriate. Develop and maintain detailed project plans (Gantt charts, milestones, KPIs) and ensure alignment with client and regulatory requirements. Oversee resource allocation, including internal teams, contractors, and third-party vendors, to optimize project efficiency. Implement risk management frameworks (e.g., FMEA, risk registers) to proactively address technical and operational challenges. 5.

Building Strong Relationships:

o Serve as a trusted advisor to clients, keeping them updated with transparent and friendly communication. o Work closely with stakeholders to find balanced solutions that meet compliance requirements while supporting business goals. o Facilitate productive discussions with leadership to share progress and insights in a clear, actionable way.

Qualifications & Experience Education :

Master’s Degree in Electronic Engineering (or related field).

Experience :

o At least 15 years in pharma/biotech/MD with deep C&Q, CSV, and Data Integrity expertise. o Proven track record in facility/equipment qualification (oral solids, sterile dosage, biotech). o Auditing experience.

Regulatory Knowledge :

o

FDA 21 CFR

Part 11/210-211, EU Annex 11, ICH

Q9/Q10, GAMP 5.

Leadership skills : Managed multi-site operations and high-profile remediation projects. Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial Talent Acquisition interview. If there’s a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.