Production Operator - Level 4

PCI TRGR Penn Pharmaceutical Services Ltd; Dundalk; On-site; EUR 40,000 - 55,000; Full time

Job summary

PCI Pharma Services is seeking a production leader to oversee day-to-day operations on a Thursday–Saturday day shift (7am–7pm). You will lead Line Leaders and Production Operators, uphold GMP practices, and drive output, quality, and yield in alignment with customer specifications.

The role requires proactive training, coaching, and cross-functional collaboration with Packaging, Warehouse, and Engineering teams.

Qualifications

• Experience leading Line Leaders/Production Operators within GMP environment.
• Ability to maintain batch records and daily operations.
• Knowledge of quality events and CAPA processes.

Responsibilities

• Provide effective on-the-ground leadership to Line Leaders/Operators; ensure GMP compliance and product conformance to customer specs.
• Ensure production reports are completed accurately and presented in Daily Operations Meetings.
• Assess and adjust the production plan with the Packaging Manager.
• Prioritise resources across production lines to meet outputs.
• Coordinate prioritisation of kitting with Warehouse and engineering needs.
• Monitor batch changeovers, line clearance, and start-up processes for compliance.
• Track line outputs, address under-performance, and drive timely corrective actions.
• Maintain customer product quality to defined standards.
• Oversee quality events with Line Leaders; ensure timely closure.

Skills

Leadership

GMP compliance

Production planning

Training

Team coordination

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.

Shift- Thursday-Saturday day shift (7am-7pm)

Description Responsible, in conjunction with the Packaging Manager and Line Leaders for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.

Responsibilities

• Provide effective ‘on-the-ground’ leadership to Line Leaders / Production Operators, ensure adherence to GMP practices and products conforming to customer specification:
• Ensure production reports are completed accurately and report as required in Daily Operations Meetings.
• Assess and modify the production plan with the Packaging Manager.
• Prioritise and designate resources across production lines.
• Prioritise kitting requirements with the Warehouse team.
• Prioritise engineering requirements with the Engineering team.
• Monitor the compliance and effectiveness of batch changeovers i.e. line clearance, booking-in of batch components and line start-up.
• Monitor production line outputs, elevate under-performance and ensure timely corrective actions are being implemented.
• Ensure customer product quality is maintained to expected standards.
• Manage the completion of quality events in an accurate and timely manner with relevant Line Leaders.
• Ensure Line Leaders receive active support and training as required.
• Manage new / existing operator training in conjunction with Line Leaders.
• Ensure compliance in employees time and attendance and elevate as required.
• Complete quarterly Quantum conversations with all Line Leaders and Operators as designated by the Packaging Manager.
• Work positively with all Production Operators, Team Leaders, Engineers and Packaging Manager at all times.
• Ensure safe work practices are being always followed and report any defects immediately to the Packaging Manager and Safety Officer.
• Deputise for the Packaging Manager / 2nd Team Leader on a short-term basis for holiday / illness cover.
• This role demands flexibility to changes in shift patterns at short notice.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
• Assist in all technical aspects and projects as and when required by the Packaging Manager.

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.