- Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utility systems.
- Manages projects including development of project scope and estimates, initiation of requests for capital when required, the specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ and final documentation in accordance with acceptable engineering practices.
- Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
- Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
- Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws, and regulations.
- Provides work direction to engineering support staff.
- Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
- Follows department processes and regularly makes recommendations on these processes.
- Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
- Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
- Analyzes data and presents it in appropriate forms.
- Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.
- Bachelor of Science Degree in Engineering, or similar and experience sufficient to successfully perform the essential functions of the job.
- Two years of Good Manufacturing Process manufacturing experience required.
- Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
- Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
- Mechanical and electronic ability and aptitude to assist with equipment troubleshooting.
- Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues, train, and provide work direction to operators and production service technicians.
- Understanding of and adherence to GMP practices and FDA regulations.
- Knowledge and ability to implement FDA or regulatory requirements as necessary.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.