Proven ability to accomplish projects independently, provides technical leadership for projects and/or programs of major significance to the Company, assuring that projects or initiatives are in alignment with site and business goals and strategies. Provides significant contributions on project teams and leads multi-functional teams. Demonstrates the ability to successfully plan complex engineering and technology projects and sustain high quality engineering and technology contributions. Provides recognized expertise in engineering/technology methodologies, and in developing approaches for successful project completion. Interfaces with all company groups and key business partners. Proactively looks for and recommends improvements in site processes and procedures. Recognized as a leader, giving significant technical direction and mentoring/training to junior staff.
- Assures major projects or initiatives are in alignment with site and business goals and strategies. Proactively looks for and recommends improvements in site processes and procedures. Leads conceptual studies for site capacity analysis and efforts for support of new product launches.
- Applies expert knowledge and experience in relevant subject areas that is acknowledged both inside and outside of the Company. Makes major intellectual contributions to the engineering/technology direction of a project or team.
- Works on or initiates projects or programs that are complex and have considerable technical risk. Provides significant contributions on project teams and leads multi-functional teams addressing major or multi-site projects. Coordinates information across project teams to facilitate project execution. Effectively communicates plans for novel programs or project ideas or engineering/technology directions both internally and externally.
- Assumes complete technical responsibility for a project area. Provides recognized expertise in engineering/technology methodologies, and in developing approaches for successful project completion. Manages, coordinates and oversees development of project design documents. Communicates and applies thorough knowledge of relevant site processes, equipment and facilities. Maintains cognizance of the state-of-the-art in the industry to assure the company utilizes current technology.
- Exemplifies cGMP compliance within the workplace by following and promoting site cGMP procedures. Incorporates cGMP and regulatory compliance into all assigned activities. Provides safety leadership within the workplace by following and improving site safety procedures. Proposes new methods for increased compliance.
- Reviews major project estimates for design, equipment, installation, labor, materials, and other related costs. May prepare project forecasts and schedules and tracks costs. Participates in site capital planning process.
- Reviews construction, installation, and commissioning work to ensure conformance to established site procedures, specifications, and industry standards.
- BS +15 years Engineering Degree or MS +12 years
- BS +18 years Non-Engineering Science Degree or MS +16 years
- Requires technical, safety and cGMP compliance training
- Demonstrated track record of increasing professional responsibilities
- Minimum 12 years experience in project management of capital projects, plus two (2) significant projects, defined as costing $25M or more.
- Minimum 12 years engineering experience in a pharmaceutical/biotech environment. Incumbent must demonstrate having an understanding of pharmaceutical/bio-technology industry along with technical proficiency.
- Strong organizational, interpersonal, oral and written communication skills
- Prioritizing multiple commitments and technical problem solving ability
- Ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.