Project Engineer

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:

This role involves generating and approving User Requirement Specifications, collaborating with engineering and site functions to specify, develop, and procure equipment and facilities, and successfully planning, executing, and delivering multiple projects with urgency while managing shifting priorities. Key responsibilities include leading teams to achieve project scope, creating and managing MS Project plans, tracking project costs, and communicating progress to stakeholders. The role also includes providing technical solutions for new business quotations, executing equipment trials and qualifications, managing facility and utility qualifications, and training technicians and engineers on new or modified equipment and processes.

Main Responsibilities:

• Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and Engineering standards, procedures, and systems.

• Development and maintenance of the materials, tooling and component specifications and ways of working including but not limited to databases, specifications, templates, SOP’s, and training.

• Completion and support of IQ, OQ & PQ activities, and complete reports.

• In conjunction with the Engineering group participate in Continuous Improvement Projects as required, including all OEE projects to ensure improved efficiencies, reduced waste, and cost.

• Work alongside Site Project Team to support such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.

• Drive a Right First-Time culture within operations to deliver a Zero Defect performance.

• Deliver products of Value at Optimal Cost.

• Work alongside Site Project Team to sustain the knowledge, capability, and competency with the Engineering & Operational team to support ongoing and changing technologies employed to meet the business objectives.

• 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.

• 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.

• To identify self-development needs for future performance.

• Provide training, support and direction to trainees / apprentices when required ensuring professional standards of workmanship and competence are achieved.

• 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.

• Training Level Specific Responsibilities

Requirements

• Experience in Engineering within an allied industry.

• Educated to BTEC HND or degree level in a Technical, Engineering, Packaging or a Science subject with previous experience working in a technical 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.

• Detailed understanding of equipment & facility and engineering issues and processes.

• Previous office and operational based packaging experience in a Pharmaceutical or FMCG business is essential.

• Experience in Pharmaceutical Project Management. 3–5-year Project Engineer experience (inclusive of apprenticeship or equivalent).

• Sound working knowledge of cGMP, 21CFR Part11, and GAMP “Current”.

• Communication skills to interact with internal and external customers at a senior level.

• Strong Team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, suppliers, and tradesmen.

• Be able to work as part of a team.

• Ability to influence and collaborate at all levels to achieve company targets.

• Be able to problem solve under high pressure situations.

• Has complete understanding of safety legislation, GMP and statutory requirements expected of them whilst carrying out engineering duties.

• Competent AutoCAD user with the ability to create and modify existing 2D drawings.

• GMP Skill Level 1 is essential for this role (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001

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.