Technical Operations Manager (Pharma)

  • Cork
  • Permanent
  • JO-1810-63926_1544178631

Summary

Pharma Client in East Cork have a requirement for a Technical Operations Manager. Permanent position, amazing opportunity, role sits just below SLT Level.

  • The Technical Operations Manager within Engineering is responsible for the leadership and management of the technical operations team of engineers and subject matter experts-guidance and support for a specific array of systems such as Aseptic Manufacturing Processes, CIP/SIP, Clean Utilities, HVAC, Packaging and Instrumentation.
  • The Technical Operations Manager will leverage engineering expertise both in the company and industry to optimize the life cycle management of all assets, from planning through disposal, and is accountable for performance of all equipment onsite.

    RESPONSIBILITIES:

  • Management of Sterility Assurance Operations team
  • Makes use of expertise at the site and corporate levels for solving problems and leveraging solutions across all sites. Identify and resolve issues and conflicts.
  • Partner with Production platforms in order to align on goals and priorities
  • Set clear goals and objectives for team. Mentoring and coaching of team.
  • Lead NPI programs
  • Coach team on process knowledge, chemistry and build mastery among team
  • Lead yield improvement program across all unit operations
  • Build consistent structured root cause analysis program
  • Accountable for performance of technical operations team against site metrics (Quality, Safety, Schedule adherence, Cost)
  • Remain current on state-of-the-art for systems, and for the appropriate adoption and use of new techniques and technology.
  • Develop, maintain, and justify the departments' budgets.
  • Develop team metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based on the benchmarking data.
  • Maintain an environment that promotes flexibility, consistent practices, and efficient operations, which prepare us for current and future production demands.
  • Lead in the development of the Engineering team vision, mission, strategies, goals and objectives that ensure the department achieves the company goals.
  • Lead and support multiple priorities in order to comply with the appropriate planned schedules.

Operations and Maintenance:

  • Manage Yield improvement programs
  • Support development of, or approve operation and emergency procedures for the safe, efficient and effective operations of systems.
  • Review performance data and make recommendations for improvement of system operations.
  • Support systems failure modes and effects analysis, approving maintenance standards and techniques. Support and review reliability and failure data, and implement actions needed to improve efficiency, effectiveness, and reliability of systems.
  • Develop information about system cost and life, and supports the Long Range Plan for equipment
  • Develop, evaluate, approve and document system changes.
  • Assist the sites in system troubleshooting, after exhausting local maintenance and engineering expertise and take action as necessary to prevent future occurrence throughout the network.

Project Management:

  • Manage NPI program
  • Working with clients, as appropriate (e.g. PD, Quality, Manufacturing), to develop and specify engineering standards, specifications, equipment selection and design.
  • Develop metrics to support procurement strategies for equipment, inventory management, spares and preventative maintenance.
  • Ensure designs optimize the total life cycle of the asset, from both a cost and effectiveness standpoint. Ensure long term value is not sacrificed for short-term cost or schedule considerations.
  • Ensure proper commissioning standards are developed and used, and qualification processes are implemented.
  • Develop, owns and maintains standard system boundaries and criticality for qualification purposes.
  • Use their network to provide engineering support to the commissioning team, to resolve escalated technical issues and conflicts, as required.

Requirements

  • PHD in Chemistry or Chemical Engineering preferred
  • Degree in Chemical Engineering or Process Engineering.
  • 10 years experience in engineering in biotech/pharmaceutical industry supporting manufacturing (quality, process development, manufacturing, clinical manufacturing)
  • Significant engineering experience with specific specialized expertise in Upstream Processes, Downstream Processes, Oral Solid Dosage, CIP/SIP, Clean Utilities, utilities, HVAC, Packaging, Devices, Instrumentation or LEED Programs
  • Experience in executing engineering projects
  • Experience in new product introductions.
  • Knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to systems and equipment and associated automation systems.
  • Strong team management skills with demonstrated ability to set clear direction, develop staff and manage performance
  • Strong communication, relationship building, leadership and mentoring skills

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