Sr Production Engineer (Columbus)

Sr. Production Engineer

Working as part of a multi-disciplinary team, the Sr. Production Engineer will manage multiple tasks simultaneously, as well as projects and project timelines. This role includes creation of project specific documentation, driving project procurement, implementation, and project closure in an FDA regulated environment.

Acting as a Subject Matter Expert, the Sr. Production Engineer will support installation / start-up of manufacturing process equipment for a newly constructed barrier isolated aseptic fill-finish facility as well as support continuous improvement projects for the traditional liquid filling facility.

This individual will chair meetings, present topics to the leadership team, provide thorough and professional communication throughout all levels of the organization.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Support new production and development equipment through vendor activities during installation, commission and qualification activities.
• Identify and track key process metrics to identify improvement opportunities.
• Develop and implement improvements through cross-functional interactions.
• Increase process equipment availability through reduction of breakdowns.
• Work with manufacturing personnel to develop, review, revise, and maintain SOPs, operational, maintenance for all current process / filling equipment and maintenance processes.
• Partner with R&D with managing new product development project plans.
• Review new equipment specifications provided by the Architectural / Engineering firm.
• Review new equipment submittals from the Construction Management / General Contractor for conformance to A / E specification.
• Collaborate with commissioning agents on new equipment.
• Coordinate Factory / Site Acceptance Testing on new equipment.
• Collaborate with in-house equipment and computerized system validation groups to support preparation and execution of validation protocols for new or modified equipment.
• Assure compliance with GMP requirements, adherence to SOPs and use of the change control system.
• Provide training to production / maintenance employees on new or modified equipment.
• Independently evaluate existing equipment, recommend and source new components for upgrading and automating equipment.
• Proactively identify technology and process gaps in manufacturing processes as well as opportunities for safety, cost, and product quality improvement.
• Analyze equipment malfunctions and failures and accordingly develop corrective actions.
• Closely interact with the maintenance technicians to develop, implement, and improve maintenance practices and procedures.
• Support Shut down activities and scheduling of process improvement work.
• Perform any other tasks / duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and / or ability required.

Preferred Qualifications

Knowledge / Skills Needed

Physical Environment and Requirements

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.