Job Information
PCI Pharma Services Process Engineering Manager in Stamullen Co. Meath, Ireland
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.
Main purpose of job:
The main purpose of an Engineering Process Manager is to ensure that the packaging processes are efficient, compliant, and capable of consistently delivering high-quality pharmaceutical products to the market. This involves a combination of technical expertise, regulatory knowledge, project management skills, and a focus on continuous improvement while overseeing and optimizing the engineering processes involved in packaging of pharmaceutical products. This involves managing and improving the processes related to production. The role also involves ensuring that the packaging processes comply with regulatory requirements, are efficient, cost-effective, and meet the highest quality standards.
Main responsibilities:
Lead the process engineering team in the design, development, and optimization of pharmaceutical packaging processes, ensuring compliance with regulatory requirements, industry standards, and operational best practices.
Collaborate with cross-functional teams, including, quality assurance, regulatory, validations project engineering , CI team and operations, to support the development and introduction of new packaging technologies, materials, and equipment, while ensuring seamless integration within existing processes.
Drive process improvement initiatives, utilizing methodologies such as lean manufacturing, Six Sigma to identify opportunities for efficiency gains, waste reduction, and quality enhancement in packaging operations.
Establish and maintain process-related documentation, including process validation plans, standard operating procedures (SOPs), and engineering change controls, ensuring alignment with regulatory requirements and current industry practices.
Provide technical expertise and guidance in troubleshooting packaging process deviations, implementing corrective and preventive actions (CAPAs), and conducting root cause analyses to address quality and performance issues.
Lead and support continuous improvement projects aimed at enhancing packaging line efficiency, capacity expansion, and the implementation of automation and digital technologies to optimize production and reduce human error.
Foster a culture of safety, quality, and operational excellence within the process engineering team, providing mentorship, training, and career development opportunities to enhance engineering capabilities and competencies.
Identify team members development needs and coaching for future performance.
Ensure that all Process Engineering functions are audit ready at all times and in full compliance with the global regulatory authorities’ requirements and expectations.
Provide a documented framework to ensure all Process Engineering activities are undertaken are in accordance with current statutory, regulatory and company EHS, cGMP and Technical Services standards, procedures and systems.
Development and optimisation of the Process Engineering ways of working including but not limited to databases, specifications, templates, SOP’s and training.
Design, Development and optimisation of all primary, secondary packaging tooling storage, control, locations and processes.
Working in conjunction with Procurement to identify preferred suppliers for engineering services and materials.
Drive a Right First-Time culture to deliver a Zero-Defect performance.
Build, develop and sustain the knowledge, capability and competency with the Technical Compliance team to support on-going and changing technologies employed to meet the business objectives.
Support Rapid and flexible attention to all production set-ups, breakdowns & faults so as to ensure OTIF is adhered to in full and product loss is minimised.
Ensure the technical compliance of all new process.
introductions including upgrades and or modifications ensuring efficiency is maximised, but SQDCP are maintained.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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.
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.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled