Project Engineer

Overview

At PCI Pharma Services, we specialize in bridging life-changing therapies to biopharma companies and patients worldwide. We focus on investing in people who drive progress and create impactful futures. We are expanding our global teams to pioneer new developments.

Role Summary

The Project Engineer will handle engineering duties including the specification, development, procurement, and implementation of site facility and production equipment and tooling that align with company and client requirements. The role requires collaboration with internal departments and suppliers when defining new equipment to ensure suitability. Identifying future capital projects and managing capital requests are key aspects, ensuring projects are delivered timely and within budget.

Key Responsibilities

• Maintain adherence to safe work practices and report near misses promptly.
• Specify and procure facility and technical tooling needs.
• Ensure engineering and technical projects are successfully introduced within schedule and financial plans.
• Coordinate and execute Factory and Site acceptance testing.
• Prepare and maintain all technical documentation including tooling logs, setting sheets, maintenance schedules, and others for all new equipment.
• Ensure all operational activities comply with regulatory, statutory, EHS, cGMP, and company standards.
• Manage project delivery to meet timing, cost, and quality targets.
• Maintain technical operations documentation, databases, specifications, SOPs, and training materials.
• Manage site tooling capability databases and technical drawings.
• Create technical drawings and templates supporting tooling, facility, and engineering needs.
• Participate with operations in Continuous Improvement Projects, including OEE initiatives to boost efficiency and reduce waste.
• Support technical, product, and process reviews to resolve operational issues.
• Promote a culture of “Right First-Time” to achieve zero defect outcomes.
• Deliver value-added products at optimal costs.
• Monitor emerging technologies and market trends to identify investment opportunities, reporting recommendations to senior leadership.
• Develop knowledge and competencies within the Technical Operations team to meet evolving technological demands.
• Foster a workplace that reflects PCI Pharma Services’ values and behaviors.
• Collaborate broadly across the organization to enhance performance.
• Manage ad hoc assignments and specific projects within capability scope.
• Perform other related duties to support company goals as necessary.

Qualifications & Experience

• Level 7 Engineering degree, trades qualification, or equivalent.
• Minimum two years’ experience in engineering roles.
• Strong goal setting, communication, and progress tracking abilities.
• Effective multitasking and prioritization skills.
• Proficient at problem solving and troubleshooting with a proactive and dynamic approach.
• Self-motivated and result oriented.
• Flexible to work various shifts as needed.
• Adept at collaboration and adaptable to change.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word).
• Previous project engineering and packaging experience in pharmaceutical or fast-moving consumer goods sectors.
• Comprehensive understanding of facility and engineering processes.
• Positive attitude and excellent interpersonal communication at senior levels.
• Competent as a team player capable of giving clear instructions and training to colleagues, suppliers, and tradesmen.
• Experienced in designing and developing new equipment for line efficiency improvements.
• Ability to influence cross-functionally to achieve targets.
• Professional representation of the company and strong integrity.
• Able to work independently and collaboratively.
• Reliable with noteworthy problem-solving capabilities.
• Willingness to travel on company business when required.

Preferred Attributes

• Exposure to GMP or regulated environments.
• Experience with Lean Manufacturing principles and tools for continuous improvement.
• Familiarity with cGMP, 21 CFR Part 11, and current GAMP standards.
• Knowledge of blister pack tooling design and production processes.
• Experience creating or modifying PLC programming.

Equal Opportunity Statement

PCI Pharma Services is committed to equal employment opportunities without discrimination based on race, color, religion, age, gender, disability, or any protected status. Our focus on diversity, equity and inclusion guides our work environment and corporate culture.

Location and Employment Type

This full-time position is based onsite in Stamullen, County Meath, Ireland.