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.
The Senior Manager, Automation Engineering will support ongoing PCI operations engineering through technical assistance and management as it relates to Automation & Manufacturing Systems and Engineering.
Manage technical resources supporting automation and operational technology functions across various PCI Ireland sites. Provides strategic support to the business for development and compliance. Develop and maintain strategic roadmap for Automation Engineering, including upgrades and obsolescence. The incumbent must exhibit strong customer communication skills and have in-depth technical knowledge of process control systems and equipment used in Pharmaceutical packaging and utility systems.
Expected results from this position would include hands-on support of automated systems in manufacturing, successful troubleshooting of automated process equipment and process systems, coordination of direct team members, coordination of contractors, and excellent execution of projects.
Key Responsibilities
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Lead and develop the automation group at PCI sites in collaboration with Engineering Management.
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Maintain, provide support, and update various system software on Production lines, Facilities and systems as identified.
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Develop and maintain procedures and best practices for cost control, safety, capital projects, utilities, controls engineering throughout PCI automation and controls activities.
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Manage equipment, utilities controls network with the use of PLC, remote I/O, panel view, and servo motion.
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Translate business needs into Automation processes by leveraging the extensive experiences within the automation controls team.
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Partners with operations and operations engineering, site leadership, equipment vendors, and parts suppliers to plan and coordinate modern technology installations, upgrades, and overhauls for processes, utilities, and systems.
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Review existing and new processes, and if necessary, design systems to improve system/plant efficiencies, costs, and quality. Assist direct reports with the development of employees to help them achieve career goals.
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Oversee Automation Engineers and contractors at multiple sites
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Prepare budgets for automation CAPEX spending for projects with controls for budget, scope, and schedule adherence.
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Participates in audits and inspections as an Engineering and Automation SME and supports QA in development of regulatory and customer audit responses.
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Responsible for Deviations and quality elements relating to automation systems.
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Maintain system/data integrity and identify performance and security improvements.
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Perform Data Integrity Risk Assessments (DIRA) and FMEA on new and existing systems.
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Responsible for routine system application (i.e., set up new users. roles, groups, data set up, software configuration, etc.)
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Administer/manage machine / line backups and the recovery in the event of discontinuity of services.
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Investigates and troubleshoots technical problems of increasing complexity.
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Develop, assess, and maintain disaster recovery procedures.
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Administers change control, and backup/ recovery procedures to maintain validated and compliant status of system.
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Lead the planning and execution of projects for computerized infrastructure change, upgrades, and process improvements.
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Contributes to design of new applications and solutions, prepare user requirement (URS) and Change Management
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Develop and maintain cross-functional relationships with partner business organizations to understand requirements, develop stakeholder priorities, and manage expectations.
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Develop and implement automation lifecycle strategy including identification of opportunities for continuous improvements, operational efficiencies, and system reliability.
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Provide regulatory support and technical strategies during major authorities' interactions and/or inspections.
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Ensure safe work practices are being always followed, report any near misses immediately to the EHS Department.
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Conduct 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:
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Bachelor’s or associate degree in Engineering or technical discipline (i.e. Electrical, Chemical, Mechanical, Electromechanical or similar) May substitute experience in lieu of educational requirements.
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3-5 years’ experience working in Automation management and Control Systems
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3-5 previous experience as a manager in a GMP, Biotechnology or Medical device environment
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3-5 years in a supervisory / people management role.
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Experience in designing, building, deploying, and supporting both execution systems in a regulated environment
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Must have proven experience in hands-on programming and configuration of Programmable Logic Controllers (PLC), and Supervisory Control & Data Acquisition (SCADA).
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At least 3 years of previous experience as a manager in a GMP Biotechnology or Medical device environment.
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Substantial experience in Automation Engineering and Controls Engineering 10+ years of experience
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Read, troubleshoot, and repair hard-wired control systems using schematic and wiring diagrams.
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Capable of troubleshooting, programming, and configuring PLC ladder logic and HMI/ SCADA database and screens.
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Strong organizational skills coupled with keen attention to details. Strong verbal and written communications skills.
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Proven track record of showing how results were delivered through management/leadership of others. Ability to manage multiple tasks and set priorities.
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Ability to handle multiple projects simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards. Use organizational skills to prioritize and resolve project issues.
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Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
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Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
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Self-motivated with a results driven approach.
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Flexibility to work across different shifts on request in line with business needs.
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Adaptable and ability to work collaboratively.
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Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
Desirable:
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Experience in programming and troubleshooting of Siemens, Breckhoff, Allen Bradly, and B&R hardware, software systems and controls.
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Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
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Effectively support internal and external relationships, key stakeholders, and vendors.
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Strong understanding of team and group dynamics. Hands on and agility for working in a fast-paced CMO environment.
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Effectively communicates and collaborates within levels of the organization
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Excellent negotiator who is a creative problem solver and team player.
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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.
