Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Summary of Role
Working within the Engineering function for PCI Pharma Services (Ireland Sites) the Reliability Engineer will act as the Subject Matter Expert (SME) for assigned packaging equipment within the technical function of Engineering. The Reliability Engineer will display strong technical ability and have interpersonal and communication skills that build the strongest of relationships at department and site level.
The Reliability Engineer will have a proven track record in troubleshooting equipment issues and be capable of understanding and optimising machine performance, be strong in a team environment and possess excellent coordination skills.
Primary Responsibilities:
- Analyse current processes to assess performance, identify improvement opportunities for equipment reliability, preventive and predictive maintenance, and condition monitoring.
- Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment / systems.
- Using SMED principles identify opportunities to improve the consistency and RFT of our batch change-over / machine setting activities.
- Assist the Project Engineering function with the transfer of new equipment from the validation to commercial phase of our NPI projects.
- Implement a critical spares program based on OEM specifications, ongoing maintenance programs and the predictive maintenance program.
- Ensure the calibration of all relevant engineering equipment is maintained appropriately.
- Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures.
- Solving complex problems, project management, equipment lifecycle management and operational excellence.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
- Work with the Continuous Improvement team and Department Managers to deliver operational excellence within PCI Ireland focusing on the warehouse functions.
- Design, implement, review and action critical KPIs for processing equipment.
Requirements:
- Minimum of 5 years’ experience in a pharmaceutical, medical device or similar environment.
- Experience in change control, management of change, non-conformance, corrective and preventative actions and validation practices.
- Excellent communication skills, both verbal and written.
- Knowledge of pharmaceutical packaging equipment, packaging materials, technologies and challenges with each.
- Experience in a GMP or Regulated Environment.
- Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
- 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.
- Adaptable and ability to work collaboratively.
- Effective communication – internal and external.
- Team working – display obvious signs of ability to work in high performing complex teams.
- Committed to the highest levels of integrity, ethics and professionalism.
- Excellent analytical and critical thinking skills with a record of successfully change management.
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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.
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What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
