We are seeking an experienced CQV Area Lead to oversee commissioning and qualification activities for API (Active Pharmaceutical Ingredient) equipment at the MSD Ballydine site. This is a full-time contract position for an initial duration of 12 months.
The successful candidate will lead a team of CQV Engineers throughout the project lifecycle, ensuring alignment with GMP standards and project objectives.
Responsibilities
* Lead and manage a team of CQV Engineers across all project phases.
* Develop and implement Validation Master Plans, Commissioning Master Plans, and project-specific procedures.
* Author, review, and approve SATs, IQs, and OQs for API equipment.
* Drive the Design Review (DR) process and conduct GMP Risk Assessments (FMEA).
* Define and execute the appropriate Commissioning and Qualification strategy for API systems.
* Review technical documentation from early design stages to ensure GMP and CQV compliance.
* Investigate and resolve technical issues in collaboration with engineering teams and equipment vendors.
* Ensure project execution adheres to company guidelines, departmental procedures, and safety standards.
* Participate in Mechanical Completion activities including walkdowns, punch list management, and system acceptance.
* Prepare and monitor CQV schedules and progress reports.
* Coordinate daily activities of CQV Engineers and ensure timely delivery of tasks.
* Apply project management principles to coordinate CQV activities and reporting.
* Manage and coordinate contractors and vendors during commissioning andqualification phases.
* Prepare and deliver Final Handover Reports to client stakeholders.
Required Qualifications & Experience
* Bachelor’s degree in Engineering, Life Sciences, or related field.
* Significant experience in CQV roles within the pharmaceutical or biotech industry.
* Proven experience with API equipment and related systems.
* Strong knowledge of GMP, validation lifecycle, and regulatory requirements.
* Proficiency in writing and reviewing CQV documentation.
* Experience with project management tools and methodologies.
* Excellent communication, leadership, and stakeholder management skills.
Desirable Skills
* Familiarity with automation systems and data integrity principles.
* Ability to work in a fast-paced, multi-disciplinary project environment.
About NRL
The NRL Group connect 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.
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