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- Tasks: Lead the commissioning of cutting-edge biotech equipment and ensure smooth operational handover.
- Company: Join a pioneering biotechnology start-up in North East England, shaping the future of pharmaceuticals.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Be part of a revolutionary team making a real impact in the biotech industry.
- Qualifications: Degree in Engineering or Project Management; extensive experience in biotech commissioning required.
- Other info: Ideal for those passionate about innovation and excellence in the pharmaceutical sector.
The predicted salary is between 43200 - 72000 £ per year.
We are seeking a highly experienced and driven Commissioning Manager to oversee the transition from equipment installation through commissioning and handover to operations at our client’s state-of-the-art biotechnology start-up facility in North East England. This role requires a strong background in pharmaceutical plant commissioning and start-up and a proven ability to manage multiple equipment vendors and internal stakeholders to deliver on time and to the highest standards.
Responsibilities:
- Lead the transition of systems from installation through commissioning to operational readiness, ensuring all handover milestones are completed to project and GMP standards.
- Manage the delivery, installation, and commissioning of multiple process equipment vendor packages, coordinating closely with vendors and internal CQV teams.
- Implement and enforce robust Site Handover Processes, ensuring clear ownership transition from construction to commissioning and ultimately to operations.
- Organise and facilitate P&ID walkdowns and system handover meetings with internal stakeholders, end users, and project engineering teams.
- Serve as a primary liaison between cross-functional teams, ensuring that engineering, automation, operations, and quality stakeholders' needs are met or exceeded.
- Develop and maintain detailed handover schedules, track progress against critical path, and proactively resolve issues that may delay startup readiness.
- Ensure safety, quality, and compliance are upheld throughout all phases of commissioning and start-up.
- Apply prior experience as a Commissioning Manager to drive operational readiness and support a smooth transition to commercial manufacturing.
Qualifications & Experience:
- Degree in Engineering, Project Management, or related discipline.
- Extensive experience in commissioning and start-up of pharmaceutical or biotech manufacturing facilities.
- Proven experience managing multiple vendor packages, FAT/SAT coordination, and equipment turnover.
- Strong working knowledge of GMP, CQV lifecycle, and site acceptance and handover processes.
- Excellent stakeholder management skills with the ability to balance competing priorities and communicate effectively at all levels.
- Strong organisational and leadership skills, capable of managing detailed schedules and high volumes of concurrent system transitions.
Contact Detail:
Tandem Project Management Ltd. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Commissioning Lead - Biologics - UK
✨Tip Number 1
Network with professionals in the biotechnology and pharmaceutical sectors. Attend industry conferences, webinars, or local meetups to connect with individuals who may have insights into the commissioning lead role or know of openings at companies like ours.
✨Tip Number 2
Familiarise yourself with the latest trends and technologies in biotech commissioning. Being knowledgeable about current practices can help you stand out during informal discussions or interviews, showcasing your commitment to staying updated in the field.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences that demonstrate your ability to manage multiple vendor packages and ensure compliance with GMP standards. Real-life scenarios can illustrate your problem-solving skills and leadership capabilities effectively.
✨Tip Number 4
Research our company culture and values at StudySmarter. Understanding what we stand for will help you align your responses during conversations and show how you can contribute to our mission, making you a more attractive candidate.
We think you need these skills to ace Commissioning Lead - Biologics - UK
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in commissioning and start-up of pharmaceutical or biotech facilities. Emphasise your project management skills and any relevant qualifications that align with the job description.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for the Commissioning Lead role. Mention specific experiences where you successfully managed vendor packages or led commissioning projects, showcasing your ability to meet GMP standards.
Highlight Stakeholder Management Skills: Given the importance of stakeholder management in this role, provide examples in your application of how you've effectively communicated and collaborated with cross-functional teams in previous positions.
Showcase Problem-Solving Abilities: Include instances where you proactively resolved issues during commissioning or start-up phases. This will demonstrate your capability to handle challenges and ensure operational readiness.
How to prepare for a job interview at Tandem Project Management Ltd.
✨Showcase Your Experience
Be prepared to discuss your extensive experience in commissioning and start-up of pharmaceutical or biotech facilities. Highlight specific projects where you successfully managed multiple vendor packages and overcame challenges.
✨Understand GMP and CQV Processes
Familiarise yourself with Good Manufacturing Practices (GMP) and the Commissioning, Qualification, and Validation (CQV) lifecycle. Be ready to explain how you've applied these standards in previous roles to ensure compliance and quality.
✨Demonstrate Stakeholder Management Skills
Prepare examples that illustrate your ability to manage and communicate effectively with various stakeholders. Discuss how you balanced competing priorities and ensured all parties' needs were met during past projects.
✨Organisational Skills are Key
Emphasise your strong organisational and leadership skills. Be ready to talk about how you developed and maintained detailed handover schedules and tracked progress against critical paths in previous roles.
