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 responsibilities:
- Management, support and mentoring of the Engineering Projects Team.
- Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and engineering standards, procedures, and systems.
- Ensuring that projects are achieved within the agreed timescale, cost, and quality.
- Responsible for the technical 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.
- Development and maintenance of the project engineering ways of working including but not limited to databases, specifications, templates, SOP’s, and training.
- Provide update and Maintenance of the site facility capability databases and specifications including customer and / or auditor ‘friendly’ electronic and hard copy documents.
- Provide update and Maintenance of the site tooling capability databases and specifications including customer and / or auditor ‘friendly’ electronic and hard copy documents.
- Provide update and Maintenance of the technical drawing data base, this is to include the generation, recording, filing and archiving of withdrawn / superseded technical drawings and associated documentation.
- 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.
- In conjunction with the operational group assist in technical, product and process reviews to resolve operational, performance and functional issues.
- Drive a right-first-time culture within operations to deliver a zero-defect performance.
- Monitoring of future technologies and market trends identifying areas for potential investment including reporting and recommendations to senior members of the PCI Pharma Services group.
- Build, develop and sustain the knowledge, capability, and competency with the Engineering Projects team to support ongoing and changing technologies employed to meet the business objectives.
- Create and sustain a working environment that promotes the PCI Pharma Services values and behaviours.
- Via projects design, implement and maintain the control strategy for the introduction of new Serialisation equipment or processes.
- Manage and process all HR and departmental documentation for the team members including overtime forms, sickness related documents, absence request forms, annual leave and probationary reviews and quarterly conversations.
Scope and Authority:
- The job holder is responsible for adhering to the company’s SOPs, Health & Safety, cGMP, and other regulatory guidelines themselves and for team members and contractors under their supervision whilst operating onsite as well as offsite locations including but not limited to customers and suppliers’ addresses.
- The job holder has direct people management responsibilities for their team members and ensuring that all KPIs and targets are met individually and by the team.
- The job holder is responsible for managing and maintaining capital and departmental project budgets as and where appropriate.
Work Experience and Skills Required
- Strong experience in Pharmaceutical / Engineering Project Management.
- Previous office and operational based manufacturing & packaging experience in a Pharmaceutical or FMCG business.
- Good working knowledge of cGMP, 21CFR Part11, and GAMP “Current”.
- Proven experience in creating business quotations and managing new process and equipment introduction.
- Detailed understanding of facility and engineering issues and processes.
- A flexible and willing attitude.
- Excellent communication skills to interact with internal and external customers.
- Ability to influence and collaborate at all levels to achieve company targets.
- Ability to represent the company in a professional and highly competent manner.
- Ability to travel on company business as required.
Qualifications:
- Educated to degree level in a Technical, Engineering, Packaging or a Science subject with previous experience working in a technical leader role or equivalent industry level experience.
- Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
- A qualification in AutoCAD Design would be advantageous
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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.
