Responsibilities
Manage a team of C&Q Engineers on a high-profile client site throughout the project lifecycle.
Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures, and commissioning and qualification protocols (SAT/Commissioning, IQ, and OQ).
Experience with Design Review (DR) process and GMP Risk Assessment (FMEA).
Identify the appropriate Commissioning and Qualification strategy for specific projects and define the required activities.
Review and follow up on technical documentation from the early design phase to ensure alignment with GMP and CQV requirements.
Investigate and resolve technical issues with assistance from our client's engineers and/or suppliers.
Ensure site project execution complies with company guidelines, departmental procedures, and safety standards.
Familiarity with Mechanical Completion procedures and Construction scope of work (walkdowns, system acceptance, punch lists, and follow-up).
Schedule preparation and progress review.
Organize and oversee daily activities of other CQV Engineers assigned to the project.
Apply project management principles to coordinate CQV activities and report to our client's PM.
Manage and coordinate contractors and vendors.
Prepare final handover reports for the client's users.
The Lead CQV Engineer reports to the department manager/site commissioning manager and is accountable for coordinating CQV resources, deliverables, and activities—from defining the validation approach and design review to system turnover and C&Q activities on site.
Qualifications & Key Competencies
Degree or equivalent in an engineering-related discipline.
10+ years of experience in commissioning and qualification activities for pharmaceutical facilities.
Strong leadership and team collaboration skills, with direct liaison experience with the client and other key project functions.
Previous experience managing or leading a C&Q team.
Strong knowledge of ISPE and ASTM E2500.
Proven experience with international pharmaceutical projects.
Ability to mentor junior staff members.
About NRL
The NRL Group connects global companies with the right people to bring engineering projects to life.
Supporting contracting companies with energy transition plans and working with our clients to create a cleaner, greener future.
We welcome applications from every walk of life and are committed to diversity within the industries we support, as a certified Inclusive Recruiter and Armed Forces friendly employer.
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