Nature and Scope

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.

BS in relevant engineering discipline (e.g. mechanical, electrical, chemical) or equivalent years of experience, required.
Minimum 8+ years engineering experience in a regulated environment required.
Ability to understand mechanical drawings, electrical/pneumatic schematics, process flow.
Ability to troubleshoot process and mechanical systems (PLC experience a plus).

Preferred Qualifications

8+ years in an FDA regulated industry
Computer proficiency (Microsoft Office/Project/AutoCAD/SolidWorks/Visio).
Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
Thorough knowledge of aseptic operations, statistics, equipment design, process control, and process scale-up.
Knowledge of aseptic pharmaceutical processes and equipment validations.
Experience with customer interaction and coordination.
Ability to prepare technical documentation / protocols.

Knowledge/Skills Needed

Continuous improvement oriented.
Understanding of computer systems operations and software.
Ability to troubleshoot and maintain manufacturing systems, equipment and processes.
Ability to author high quality technical protocols/reports (Engineering Studies, Validation protocols, summary reports, equipment specifications, and SOPS).
Ability to specify and size manufacturing systems, equipment and process equipment.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

Physical Environment and Requirements

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
Employee must be able to occasionally lift and/or move up to 25 pounds.

Must be able to work in office and manufacturing environment. Some travel may be required.

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.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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