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.
We are now looking for a Quality Engineering Specialist (12-Month FTC) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.
Summary of Role
As a Quality Engineer at PCI Pharma Services, you will play a critical role in ensuring the quality and compliance of pharmaceutical packaging processes. You will work in a dynamic environment where attention to detail and a strong understanding of regulatory requirements are essential. Your responsibilities will include quality assurance, process improvement, and collaborating with cross-functional teams to meet the highest industry standards.
Key Responsibilities
- Conduct routine inspections of packaging processes to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).
- Perform risk assessments and analysis of critical parameters in packaging operations.
- Monitor and enforce adherence to cGMP, GDP, and other relevant quality systems.
- Implement quality control procedures, including visual inspections, sampling, and testing, to verify product integrity.
- Manage non-conforming product investigations and root cause analysis.
- Maintain comprehensive records of all quality activities, including batch records, deviations, CAPA reports, and change controls.
- Assist in the creation and revision of standard operating procedures (SOPs) to align with quality standards.
- Identify opportunities for process optimization and quality enhancement.
- Provide recommendations for corrective and preventive actions to resolve quality issues and enhance efficiency.
- Participate in equipment and process validations (IQ, OQ, PQ) to ensure equipment and systems meet predefined quality and performance criteria.
- Coordinate validation activities and create validation protocols.
- Prepare for and participate in internal and external quality audits and regulatory inspections.
- Implement corrective actions in response to audit findings.
- Collaborate with production, engineering, and other departments to resolve quality-related issues.
- Provide training and guidance to production staff on quality and compliance matters.
- Stay updated on industry regulations and emerging trends in pharmaceutical packaging.
- Collect, analyse, and interpret data to identify trends and areas for improvement.
- Generate quality reports and metrics for management review.
- Attention to detail and a commitment to ensuring product quality and safety.
Knowledge / Skills & Experience
Essential:
- Bachelor’s degree in STEM field (e.g. business, logistics, systems engineering, supply chain management or similar). May substitute experience in lieu of educational requirements.
- Minimum 2 years’ experience working in Engineering, Quality, Manufacturing or other technical disciplines
- Adhering to and ensuring compliance with company SOPs, Health & Safety, cGMP, and other regulatory guidelines.
- Supervising activities on and off PCI Pharma Services sites, including customer and supplier locations.
- 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.
- Capability to working towards departmental goals, communicate updates clearly and ensure progress to completion meeting predefined targets.
- Ability to manage multiple tasks and set priorities.
- Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
- Self-motivated with a results driven approach.
- Flexibility to work across different shifts on request in line with business needs.
- Adaptable and ability to work collaboratively.
- Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
Desirable:
- Experience in a GMP or Regulated Environment.
- Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
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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.
