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Stamullen, Éire / Ireland
Onsite
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.
Summary of Role
Responsible for project engineering aspects within PCI Pharma Services including:
• Specification, development, purchase and introduction of site facility, and production equipment tooling and processes in line with the companies and customers’ needs
• Liaise with other departments and suppliers during the specification of new equipment to ensure fit for purpose is achieved.
• Identification of future Capital investment projects to improve the business offerings and competitive edge
• Raising of site capital application requests
• To ensure that all engineering & technical projects are introduced successfully into the business, on time and in budget.
Key Responsibilities
• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
• Specification, development and purchase of site facility, equipment and tooling needs.
• To ensure that all engineering & technical projects are introduced successfully into the business, on time and in budget.
• Coordination and execution of Factory acceptance (FAT) and Site acceptance (SAT) trials.
• Ensure the setup of all technical documentation and paperwork such as tooling logs, setting sheets, on line working sheets, planned preventative maintenance schedules, schedules covering all new equipment and plant brought onto site on the technical services department.
• Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and technical standards, procedures and systems.
• Ensuring that projects are achieved within the agreed timescale, cost and quality.
• Maintenance of the technical operations and project engineering ways of working including but not limited to databases, specifications, templates, SOP’s and training.
• Maintenance of the site tooling capability databases and specifications.
• Maintenance of the Technical Drawing database.
• Producing Technical Drawings & Templates to support business & customer needs this includes but is not limited to Tooling, Facility and Engineering drawings within scope of the job-holder’s capabilities.
• In conjunction with the operational group participate in Continuous Improvement Projects as required, including all OEE projects to ensure improved efficiencies, reduced waste and cost.
• In conjunction the operational group assist in technical, product and process reviews to resolve operational, performance and functional issues.
• Drive a Right First-Time culture within operations to deliver a Zero-Defect performance.
• Deliver products of Value at Optimal Cost.
• Monitoring future technologies and market trends identifying areas for potential investment including reporting and recommendations to senior and executive members of the PCI Pharma Services group.
• Build, develop and sustain the knowledge, capability and competency with the Technical Operations team to support ongoing and changing technologies employed to meet the business objectives.
• Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviours.
• Connect across PCI Pharma Services to drive performance.
• 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.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience
Essential
• Engineering degree (Level 7)/ Trades qualifications/ Other suitable qualification
• Two years’ experience working in an Engineering role.
• Capability to set clear goals, communicate these 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.)
• Previous office and operational based project engineering & packaging experience in a Pharmaceutical or FMCG business
• Detailed understanding of facility and engineering issues and processes.
• A flexible and willing attitude
• Communication skills to interact with internal and external customers at a senior level.
• Strong Team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, suppliers, and tradesmen.
• Design and develop new equipment to help improve line effectiveness.
• Ability to influence and collaborate at all levels in order to achieve company targets.
• Ability to represent the company in a professional and highly competent manner.
• Ability to multitask and prioritise activities.
• Ability to work on their own as well as part of a team.
• Excellent problem-solving skills.
• Dependable, reliable and shows good integrity.
• Ability to travel on company business as required.
Desirable
• Experience in a GMP or Regulated Environment.
• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
• Good working knowledge of cGMP, 21CFR Part11, and GAMP “Current”.
• Detailed understanding of blister pack tooling design and manufacturing processes.
• Use of creating/amending PLC programs.
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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.