The Sr. Manager, Process Engineering, will provide technical engineering expertise within multiple areas of responsibility including engineering, validation and equipment/system maintenance involving cross functional teams. The Sr. Manager plans, organizes, and leads cross-functional project meetings and collaborates with other functions and participates in continuous improvement meetings related to equipment improvement and project activities. This position drives collaboration with the Senior Leadership Team and affected functional managers to develop business cases, project scope, and resource requirements in alignment with site goals for improved reliability and performance of equipment. Develops and recommends new technologies to achieve cost effective and improved equipment/systems robustness. Develops plans and strategy for new product introductions. Establishes operating equipment specifications and improves manufacturing techniques/processes. Plans and delivers capital projects. Supervises and leads regional and site direct reports and develops high performance team. This position may reside in either Rockville or Camden sites.
II: Essential Functions
- Provide technical engineering oversight from development, to the implementation and routine operation on process equipment/systems.
- Build and lead cross-site process engineering teams to implement the improvement plans to achieve process equipment deliverables, timelines, and performance.
- Develop documentation to support new equipment implementation (User requirement specifications, Detail design specification, Operating and Maintenance procedures, FAT, SAT, and commissioning documents).
- Perform conceptual analysis for new capital project proposals; feasibility analysis, scope of work, basis of design, project schedule, budgetary estimate, facility utilization, risk analysis and implementation plan.
- Implement engineering standards and best practices in the design of projects, specification of instruments and equipment, oversee/ coordinate the fabrication, installation and implementation of solutions to process problems.
- Troubleshoot and aid in the repair of process equipment/systems as required to maintain GMP standards for optimal performance. Responsible for ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.
- Perform deviations/investigations/CAPAs/Change Control write-up. Provide engineering studies, technical engineering support, training and leadership to manufacturing, QA, validation, Quality Control, Validation, Facilities, and Metrology for continuous process improvement, troubleshooting, change control and deviation resolution.
- In areas of health, safety and environmental policy: Provide guidance, leadership and directives to support and comply with all policies. Contribute toward meeting departmental goals and demonstrate progress in preventing or reducing injuries.
- Manage contract engineers, and engineering service providers depending on the current projects and workloads.
- Individual with experience must have knowledge of unit operations typically used in biotech and vaccine manufacturing such as bulk manufacturing, downstream operations, formulation, steaming (SIP) and cleaning (CIP).
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
- Minimum of Bachelors degree in engineering (chemical, industrial, mechanical, or related discipline) Minimum 7 years of engineering experience in the field of pharmaceutical/biotechnology (or equivalent).
- Strive for Results, Make Decisions, Lead Teams, Develop People, Think Strategically.
- Supervises and manages direct reports in a manner that encourages collaboration and personnel development. Exemplifies leadership, integrity, and fosters the company core values. Enforces disciplinary actions as needed.
- Excellent leadership and management skills with experience managing and leading people cross-functionally with varying levels of experience
- Open communication style with strong written and verbal communication skills
- Excellent interpersonal skills including negotiating, influencing, and active listening
- Fluent with regularly used software applications (Word, Excel, PowerPoint, SharePoint, MS Project)
- A self-motivating and goal-oriented individual with proven technical engineering skills. Must have strong oral and written skills with emphasis on technical writing for deviations/investigations/CAPAs.