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Summary of Role

The Associate Director Engineering provides strategic leadership for engineering, encompassing maintenance, automation, reliability and capital projects within a pharmaceutical packaging operation. The role drives and holds accountability for operational excellence, compliance, safety, engineering performance, capital delivery and organisational capability with engineering team. The successful candidate will demonstrate strong troubleshooting capabilities, project leadership skills, and a proactive approach to identifying and implementing innovative engineering solutions that support business growth, customer requirements, and operational efficiency.

Key Responsibilities

Responsible for process engineering within PCI’s Ireland operations including:

Process Ownership & Technical Leadership
- Lead engineering, maintenance, automation and facilities teams.
- Develop engineering strategy aligned to site objectives.
- Act as the leader of technical SME for assigned manufacturing, packaging, serialization, or automation processes.
- Develop, maintain, and continually improve process knowledge, standards, and best practices across site operations.
- Provide technical leadership and coaching to operations, maintenance, quality, and engineering teams.
- Support investigations, root cause analysis, and implementation of effective CAPAs for process and equipment-related deviations.
Operational Excellence
- Lead initiatives to improve OEE, throughput, quality performance, reliability, and waste reduction.
- Apply Lean Manufacturing, Six Sigma, and continuous improvement methodologies to optimize operational performance.
- Utilize process data and performance metrics to identify trends, prioritize improvement opportunities, and deliver sustainable solutions.
- Support Right First Time (RFT) and On Time In Full (OTIF) performance objectives.
Equipment Reliability & Troubleshooting
- Provide advanced troubleshooting support for manufacturing and packaging equipment to minimize downtime.
- Partner with Maintenance and Operations teams to improve equipment availability, reliability, and maintainability.
- Identify recurring equipment issues and implement long-term corrective actions.
- Support predictive and preventive maintenance strategies to maximize asset lifecycle performance.
Automation & Digital Technologies
- Support automation initiatives including PLC, HMI, vision systems, serialization platforms, and digital manufacturing technologies.
- Collaborate with equipment vendors, OEMs, and system integrators to optimize machine functionality and performance.
- Identify opportunities for digitalization, Industry 4.0 technologies, and process automation to drive productivity improvements.
- Participate in software modifications, equipment upgrades, and control system improvements where appropriate.
Engineering Projects
- Lead or support capital investment planning, URS, FAT, SAT, commissioning and qualification execution.
- Support Automation and Digital Transformation
- Prepare business cases and technical justifications for capital investment opportunities.
- Participate in User Requirement Specification (URS) development, equipment selection, procurement, FAT, SAT, installation, commissioning, and validation activities.
- Ensure projects are delivered safely, on time, within scope, and within budget.
Compliance & Quality Systems
- Ensure compliance with cGMP, GDP, regulatory requirements, company procedures, and Good Engineering Practice (GEP).
- Generate and review engineering documentation including SOPs, change controls, risk assessments, technical reports, validation documentation, and engineering standards.
- Maintain technical drawings, equipment specifications, and engineering documentation throughout their lifecycle.
- Support internal, customer, and regulatory audits as required.
Risk Management
- Lead and participate in risk assessments including FMEA, HAZOP, machine safety, and process risk evaluations.
- Ensure engineering risks are identified, assessed, controlled, and documented.
- Support business continuity and risk mitigation initiatives.
Health, Safety & Environmental
- Champion a strong safety culture and ensure safe systems of work are followed at all times.
- Participate in EHS initiatives, risk assessments, incident investigations, and corrective action implementation.
- Identify opportunities to improve environmental sustainability, energy efficiency, and waste reduction.
- Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.

Supplier & Stakeholder Management
- Collaborate with suppliers, contractors, OEMs, and service providers to deliver engineering solutions.
- Support supplier assessment, qualification, and performance management activities.
- Build strong relationships across Operations, Quality, Validation, Supply Chain, Procurement, Clietns and Customer-facing functions.
Continuous Improvement & Innovation
- Monitor emerging technologies, pharmaceutical industry trends, and best practices.
- Identify strategic opportunities to enhance site capabilities and competitive advantage.
- Support the development of engineering standards, workflows, and operational excellence programs.
- Lead and participate in continuous improvement projects aligned with site strategic objectives.

Knowledge / Skills & Experience / Competencies

Essential:

Degree in Engineering discipline.
10+ years in pharmaceutical, medical device or regulated industry.
5+ years leadership experience.
Strong GMP, validation, quality systems and project management knowledge.
Experience managing engineering budgets and capital projects.
Strong communication and stakeholder management skills.
Demonstrated experience in troubleshooting complex process and equipment issues.
Experience of automation in an engineering environment
Experience supporting equipment qualification, validation, FAT, SAT, and commissioning activities.
Understanding of serialization systems and associated regulatory requirements.
Strong knowledge of cGMP, quality systems, risk management, and Good Engineering Practice.
Experience with structured problem-solving methodologies such as DMAIC, 5 Why, Fishbone Analysis, or RCA.
Ability to manage multiple priorities within a fast-paced operational environment.
Excellent communication, stakeholder management, and presentation skills.
Strong analytical capability with a data-driven approach to decision making.
Proficiency in Microsoft Office, Microsoft Project, AutoCAD, Visio, and CMMS systems.

Key Competencies
- Strategic Leadership;
- Engineering Excellence;
- Financial Management;
- Compliance;
- Project Management;
- Change Leadership;
- Innovation;
- Accountability.
- Technical Excellence
- Problem Solving & Analytical Thinking
- Continuous Improvement Mindset
- Leadership Through Influence
- Project Management
- Customer Focus
- Collaboration & Teamwork
- Accountability & Ownership
- Adaptability & Agility
- Communication & Stakeholder Management
- Integrity & Professionalism

Desirable:

Multi-site pharmaceutical experience.
Experience in Lean Manufacturing, Six Sigma, TPM, or Operational Excellence methodologies.
Green Belt or equivalent Continuous Improvement certification.
Knowledge of machine safety standards and CE compliance.
Experience managing capital projects in a pharmaceutical environment.

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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.

Associate Director, Engineering

Job Description