To help deliver our extended business portfolio of project services and further support our clients & suppliers, we have created an exciting opportunity to manage our process and validation portfolio.
In this role, you will be accountable for providing project, process, scientific and validation support across the business and directly to our network of customers and suppliers. As a PVM manager, you will support the delivery of equipment, process, validation and business projects. This role provides the right candidate with an exciting opportunity to lead a team in delivering an extensive range of project services across various equipment and process types.
Key Responsibilities:
1. Demonstrate leadership, team-skills, self-confidence, and effective decision-making.
2. Manage and lead the validation team.
3. Responsible for contributing, coaching, mentorship and developing own and wider team members in their development plans.
4. Intently lead process and validation discussions with the Customers and Suppliers.
5. Provide Process Engineering support to capital projects, wider teams, our suppliers and our customers, not limited to the following:
1. Design review of process equipment & process utilities.
2. Creation and development of PFDs and P&IDs (including black box P&IDs).
3. Actively facilitate & engage in hazard studies/design studies and discussions.
4. Lead, derive, and verify process-related questions and calculations e.g. flow rates, pipe & vent sizing, pressure relief. Contribute in analysis, interpretation and report on the results of process reviews, within agreed timescales and quality standards, and in accordance with project/ client requirements.
5. Actively lead problem-solving using modern RCA techniques.
6. Facilitation of HAZOP and FMECA studies.
6. Using reputation and experiences to further upsell validation lifecycle services with our Suppliers and Customers the candidate will take a lead role in this process.
7. Effectively develop, project manage and deliver these identified projects and processes that support business needs.
8. Demonstrate a structured approach to documentation planning & design. Fluent in the validation lifecycle having advanced knowledge of the CQV documentation required for cGMP process equipment and utilities within the pharma industry.
9. Ownership, development & delivery of contracted project services and documentation to our Customers and Suppliers (e.g. RTQ, DQ, C&Q, SOP writing).
10. Be GMP, GEP and legislatively current, and maintain consistent document compliance with all relevant Safety, Health and Environmental (SHE), quality and best practice requirements.
11. As a manager, you are responsible for providing clearly documented reports and records of progress, technical data, decisions, methodologies & calculations.
12. As a senior contributor, actively contribute to the overall performance and strategy of the wider business.
13. Other duties as assigned.
Key Skills & Experience:
1. Relevant Degree or comparable qualification in an engineering, science or validation discipline.
2. 3 or more years’ relevant experience in process engineering and/or validation in the pharmaceutical industry. You will demonstrate professional knowledge of principles and practices in pharmaceutical operations, as well as experience of practical, technical-based work gained in academic or industrial environments.
3. Experience of managing a team, including remote workers.
4. Having relevant experience supporting aseptic manufacturing or clean utilities would make you a great addition to the team.
5. It is essential that you are open to learning and can apply your own judgement and initiative within standard engineering or scientific practices, as well as an understanding of when to seek advice from colleagues.
6. Project Management experience, an advantage.
7. Proficient in CAD desirable.
8. Proficient in standard MS packages.
9. Having experience in packaged project management tools & ERP systems.
10. Technical writing experience.
11. Demonstrated record of ‘on time’ performance.
12. Accountable to meet stated project expectations.
13. Will be innovative & a ‘can do’ attitude - seeks innovative and novel approaches for design, function and implementation.
14. Will have the opportunity to work on a range of processes, from the conceptual stage through to detailed design, commissioning and qualification.
15. Reasonable travel to customer and supplier sites will be required.
At all times this person needs to reflect the company’s goals and values.
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