Job Title: Technical Operations Manager
- Responsible for managing technical operations team of engineers and subject matter experts.
- Management of Sterility Assurance Operations team
- Manage Cleaning Validation Program.
- 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)
- Develop, implement and utilize business tools needed to perform technical responsibilities; establish measure and evaluate metrics, taking actions based on results.
- Develop, maintain, and justify the departments’ budgets.
- Assure the appropriate level of training for all levels of the organization.
- Oversee the development, revision, review, and approval of all Standard Operating Procedures that are owned by Technical Operations.
- Provide direction on departmental and/or site priorities.
- Establish and maintain rapport with the Facilities and Engineering Global Network.
- Other such duties as may be assigned
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, 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.
- Establish and review parts standards and approvals.
- 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.
- Manage and track changes to specifications and standards, keeping system configuration current.
- Incorporate lessons learned from field and industry into standards.
- Ensure adherence to standards and good engineering practices.
- 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.
- Support the equipment excess and facility demolition processes.
- PHD in Chemistry or Chemical Engineering or equivalent course.
- Degree in Chemical Engineering or Process Engineering.
- Significant engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, Oral Solid Dosage, CIP/SIP, Clean Utilities, utilities, HVAC, Packaging, Devices, Instrumentation, or LEED Programs
- Line management experience
- Experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, deciding cost/benefit analysis)
- Advanced Degree in Engineering or Life Sciences
- Professional registration, such as a Professional Engineer license
- Significant experience in engineering in biotech/pharmaceutical industry supporting manufacturing (quality, process development, manufacturing, clinical manufacturing)
- Strong team management skills with demonstrated ability to set clear direction, develop staff and manage performance
- Significant experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, deciding cost/benefit analysis)
- Understands operational aspects of biopharma and/or engineering industries