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CQV Manager 1571
Cork
About SimoTech
SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
Why SimoTech
What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
CQV Manager 1571
SimoTech has a new opportunity for an experienced CQV Manager to serve as the subject matter expert on all project commissioning and qualification activities, and resource management for a biopharmaceutical client based in Co. Cork.
The successful candidate will have a minimum of 10 years’ experience leading CQV activities across all project functions, with a deep understanding of their requirements, development processes, and the ability to design and execute the most effective strategy.
Key Responsibilities
- Lead the CQV execution team of at least 10 CQV Engineers to ensure timely execution and compliance with SOPs and current industry regulations.
- Lead team meetings and facilitate problem-solving to ensure timely achievement of project milestones.
- Support and coordinate the transition to a digitised C&Q platform.
- Manage resource planning and CQV personnel throughout the project to align with schedule and budget.
- Manage and coordinate all equipment qualification and documentation activities, including FAT, SAT, Design Qualification, IQ, OQ, and PQ.
- Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
- Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
- Support continuous improvement initiatives by implementing best practices in project execution and quality assurance.
- Ensure that all stakeholders, including client teams, vendors, and subcontractors, adhere to established project protocols.
Qualifications
- Bachelor’s degree in Engineering, Computer Sciences, Life Sciences or similar.
- Minimum 10 years’ experience in a Pharmaceutical or Life Sciences industry with at least 5 years’ experience in a CQV Lead or Manager role.
- Extensive experience in digitalisation platforms like KNEAT.
- Strong understanding and experience with Risk-Based Verification (RBV) in line with ISPE guidelines and global regulatory requirements, ensuring CQV deliverables meet all applicable standards.
- Excellent verbal and written communication skills, with a proven ability to build strong cross-functional relationships, apply analytical problem-solving, make dynamic decisions, plan effectively, and manage stakeholder engagement and senior management reporting.
What SimoTech Can Offer
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
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