Engineering Lead, Strategic Projects

PCI Pharma Services; Stamullen; On-site; EUR 90,000 - 130,000; Full time

Job summary

PCI Pharma Services Ireland is seeking an Engineering Lead to manage a large-scale, fast-paced project within the Strategic Projects function. You will demonstrate strong technical ability and build relationships across site, global and customer teams to drive progress from design through validation.

Responsibilities include ownership of delivery, budgeting and CapEx requests; leading NPI and new equipment introductions; ensuring quality, Right First Time, and On Time In Full; and mentoring

Responsibilities

• Ownership of assigned large-scale project and progress updates.
• Represent the project status, risks and concerns to the business and customer.
• Be accountable for delivery of assigned project(s) through design to validation.
• Lead Engineering support on New Product Introductions (NPI) and tooling/equipment design and qualification.
• Lead the introduction of new fit-for-purpose equipment to the Ireland site with URS, SOPs, changes and training.

Job description

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.

Working within the Strategic Projects function for PCI Pharma Services (Ireland Sites) the Engineering lead will be primarily responsible for managing a large-scale fast paced project. The Engineering lead will display strong technical ability and have interpersonal and communication skills that build the strongest of relationships at site, global and customer levels.

Key objectives of the role will be planning, monitoring and reporting of progress and status at key milestones of the defined programme. The Engineering lead will have a proven track record in the ability to communicate and accelerate effectively, be strong in a team environment and possess excellent coordination skills.

Main Responsibilities

• Ownership of assigned large-scale project and being accountable for progress and status updates.
• Represent the project status, risks and concerns to the business and customer.
• Be accountable for delivery of assigned project(s) and ensuring quality is present and prioritised from design through to validation.
• Focus on delivery – Right First Time (RFT) and On Time In Full (OTIF).
• Support the development of the project goals and track and report on the success of the project.
• Manage the project budget, escalating when concerns appear and engage with the business to keep on track. Ownership of Capital Expenditure (CapEx) requests.
• Lead Engineering support on New Product Introductions (NPI) assisting in new tooling & equipment design, delivery & qualification.
• Lead the Introduction of new fit-for-purpose equipment to the Ireland site in a compliant and efficient manner including but not limited to User Requirement Specification (URS), Standard Operating Procedures (SOPs), new equipment forms, change controls and training.
• Support the development of PCI internal engineering processes/workflows with an aim to reduce wastage and improve efficiencies across various workstreams and initiatives.
• Support the onboarding process for new team members and mentor junior staff in their personal and professional development. Build, develop and sustain the knowledge, capability and competency within the Engineering and Projects teams to support ongoing and changing technologies employed to meet the business objectives.
• Lead the planning and execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Coordinate with cross functional teams involved in the testing ensuring effective communication is displayed and staff are always aligned.
• Ensure technical engineering documentation is completed in a timely manner as per site procedures to support project schedules of all new equipment introductions.
• Work cross functionally to define line layouts utilising Good Engineering Practice (GEP).
• Support the risk management process through involvement in risk assessment for new (or modified) equipment and new processes.
• Drafting, approval, execution, and closure of Engineering Line Trials on new packaging formats on new and existing equipment sets.
• Support the Validation process for new equipment introductions and NPI. Act as reviewer and approver on behalf of the Engineering department.
• In conjunction with Operations assist in technical, product and process reviews to resolve operational, performance and functional issues.
• Monitoring of future technologies and market trends identifying areas for potential investment including reporting and recommendations to the Site Leadership Team (SLT).
• Identification of future CapEx projects to improve the business offerings and competitive edge.
• Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and technical standards, procedures and systems.
• Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviours.
• Connect across PCI Pharma Services to drive performance.
• To undertake 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.

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 control.
• Supervision whilst operating on and off site at PCI Pharma Services sites including but not limited to customers and suppliers addresses.
• The job holder is responsible for managing and maintaining capital project budgets as and where appropriate.

It is a requirement of this role that on occasion the individual will be required to travel on company business. This may be vendor/supplier or customer based.

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, Equity and Inclusion 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.