- Reviewing the design of Mechanical systems and providing expert guidance to comply with the AbbVie Standards and Specifications.
- Generate and/or update standards in the area of Mechanical Systems for AbbVie Systems and Standards group.
- Stay current with the latest regulatory guidance and industry best practice in the area of practice such as but not limited to HVAC/Refrigeration/Containment/Chillers/Compressed Gasses/Steam.
- Able to support projects through all phases of execution including front end planning efforts and direct the development of detailed process description narratives, process flow diagrams, and P&IDs in these mechanical systems.
- Ability to direct and advise on the lay-out of these mechanical systems in manufacturing sites.
- Ability to review equipment providers and making recommendations and selections based on project requirements.
- Attending and/or coordinating factory acceptance tests and/or site acceptance tests for equipment.
- Ability to develop and present continuing education topics internally.
Key Leadership Competencies
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Can develop and implement a vision of how these systems should be designed and standardized across the company to best meet the needs of the project engineers and manufacturing sites.
- Degree in Mechanical Engineering
- 10 plus years of relevant experience required.
- Expert in developing process strategies/philosophies for Mechanical engineering projects such as but not limited to HVAC/Refrigeration/Containment/Chillers/Compressed Gasses/Steam.
- Experienced in FDA, EMA, cGMPs and other regulatory standards and requirements for mechanical processes.
- Advanced knowledge and application of cGMP as ISPE guidelines in mechanical applications.
- A basic understanding of government regulations such as EPA, hazardous waste regulations, local and federal environmental regulations, and OSHA chemical hygiene plans.
- Ability to present process designs to project and site clients
- Ability to author standards
- Ability to direct mechanical system design activities
- Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 20 % of the Time
Job Type: Experienced