Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of role:
- To provide leadership and manage Site Project Department in line with company objectives, policies and business plan. Ensures regulatory compliance of all project related activities. Gives advice and technical support for all project related capital expenditure in line with site development plan.
- To manage and process all HR and departmental documentation for the team members including; attendance sheets, overtime forms, sickness related documents, absence request forms and annual leave and staff appraisals including 1:1s, probationary reviews and PMRs
- Providing technical solutions to enable the generation and approval of all new business quotations
- Identification of future Capital investment projects to improve the business offerings and competitive edge
- Raising of URS and capital application requests
- Specification, development, purchase & introduction of site facility, equipment and tooling needs in conjunction with appropriate site functions
- Support/Execute appropriate equipment trials through to production
- Assists Department Heads in selection and validation of new systems and equipment.
- Support the introduction of new technologies and provide innovative problem solving when appropriate.
Main responsibilities:
- To manage the training requirements within the group to ensure regulatory compliance and business needs are met.
- To identify self-development needs. In conjunction with HR, to develop training plans and budgets.
- Adhere to guidelines set out in PPSL Environmental Policy.
- Demonstrate a comprehensive training policy that gives support and direction to the project team when required thus ensuring professional standards of workmanship, competence and regulatory compliance are achieved at all times.
- Maintaining close co-operation with all other departments to attain continual improvement in performance and standards of quality and reliability.
- To coordinate and manage site and operational projects to provide and bridge between construction/purchasing of new facilities and equipment into the operational phase. This will include the generation of all supporting quality documentation and change controls, risk assessments
- To manage the Project Engineering group to ensure timely completion of their activities in accordance with regulatory, GMP, HSE and contractual requirements
- To manage the site project dashboard to ensure timelines are met.
- To assist the Project Management and Business Development departments in producing detailed and accurate project costing for any fast track activities.
- Responsible for the engineering aspects of quotations and aligning of all new product introductions to the equipment and process capabilities thus ensuring efficiency is maximised but quality is maintained
- To keep abreast of technical innovations/developments within the industry as to ensure that PCI’s service offerings remain competitive in the market place.
- Maintenance of the site tooling capability databases and specifications
- Support & completion of IO, PQ activities and complete reports.
- In conjunction with the operational group participate in Continuous Improvement Projects as required, including all OEE projects to ensure improved efficiencies, reduced waste and cost.
- Producing Technical Drawings & Templates to support business & customer needs, this includes but is not limited to Packaging, Product, Facility and Engineering drawings within the scope of the job-holder’s capabilities.
- To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holders capabilities and responsibilities
- To comply with company policies, local, UK and global regulatory requirements including internal and external Health, Safety and Environmental standards at all times whilst completing tasks.
- Assist in ensuring any items in the QMS are completed within the required timescale.
- Maintaining close co-operation with all other departments to attain continual improvement in performance and standards of quality and reliability.
- Dependant on knowledge and expertise, provide support when requested to other areas of the business upon the discretion of their department manager.
- Maintain a degree of flexible working in order to support the business, when required, on weekends or after hours.
Experience:
- Experience in a pharmaceutical operations role, with a high level of expertise in operations of all dosage forms (ideal)
- Experience of working within a GMP regulated environment.
- Be able to work unsupervised to a high quality.
- Be able to complete paper work in accordance with RFI principles.
- Be competent in the use of Microsoft word and excel
- Be able to work as part of a team.
- Be able to problem solve under high pressure situations.
- Consistently demonstrate leadership behaviours.
- Ability to engage and motivate team members to strive for excellence.
- Has complete understanding of safety legislation, GMP and statutory requirements expected of them whilst carrying out engineering duties.
- A qualification in AutoCAD Design would be advantageous.
- Full time-served apprenticeship in plant maintenance or applicable engineering / science degree.
- ONC/HNC in engineering or can demonstrate equivalent knowledge
- Has complete understanding of safety legislation, GMP and statutory requirements expected of them whilst carrying out engineering duties.
Benefits
At PCI, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life. Here's what we offer:
- Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
- Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
- Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
- Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
- Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!
- Staff Engagement: We value your dedication with recognition schemes and long-service awards.
- Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
- On-Site Subsidized Canteen.
- Cycle to Work Scheme.
- Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
#LI-AT1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
