Senior Engineer
Job Summary:
The Senior Engineer provides engineering support for the efficient and effective use of the Company’s manufacturing/facilities equipment, including participation and direction of site Master Planning. The Senior Engineer will also be directly responsible for management of capital projects and all associated activity relating to the site engineering effort for new construction and manufacturing/facilities equipment installation.
Responsibilities:
- Support plans and programs for the department that will achieve the company’s yearly and long term objectives, including involvement in site Master Planning
- Develop future-plans and contingencies for construction and renovation.
- Assist in financial planning relating to capital budgets
- Execute capital project work as prescribed by the capital budget
- Generate ROI and cost justifications for ongoing systems upgrades and replacements
- Support the department’s expense budget; identify and implement cost savings plans and opportunities for department operating budget
- Maintain budgets for assigned capital project work up to $1.5MM
- Supervise outside contractors and vendor OEMs for equipment installation, start-up, repair, and routine preventative maintenance
- Implementation and management of engineering, safety, and compliance systems; creation, execution and supervision of design and validation plans
- Understanding and interpretation of PLC and instrumentation issues
- Mentoring of engineering technicians and department engineering staff
- Function as SME in multiple process and facility functional areas
- Assure maintenance of site equipment and facility drawings; read and optimize PID, arch and MEP drawings
- Oversee development of equipment qualification protocols and training documents; maintain and create detailed specifications (DDS, URS, SDS)
- Manage and document changes to equipment, project activities, and address CAPAs and Deviations within the site Quality Management System
Education/Qualifications:
- Bachelor's Degree required
- Ten years of engineering experience in the pharmaceutical manufacturing arena with detailed knowledge of pharmaceutical mfg. equipment and facility systems desirable.
- A solid understanding of cGMP’s and other regulatory requirements.
- Excellent technical (engineering) working knowledge across all pharmaceutical mfg. equipment types and in HVAC and utility areas
- A strong working knowledge and experience with validation practices and project management.
- The ability to handle multiple projects and assignments with varying priorities in a manner that meets the Company’s goals
- Capable of optimizing processes in respect to financial efficiency, system performance, or both
- Traditional office environment with frequent walking to other areas of the facility and exposure to outside elements; able to stand for long periods of time occasionally based on job demands
- Occasional business travel up to 3 weeks per year
