The posting
Nature and Scope
The Process Engineer must effectively manage multiple projects, including project timelines, documentation, procurement, implementation, and closure in an FDA regulated environment. The Process Engineer will be required to develop procedures and systems to assure that manufacturing operations and maintenance meet Current Good Manufacturing Practices (cGMP), operational efficiency requirements, and lead efforts to identify opportunities for improvement.
The Process Engineer will support commercial manufacturing, Research & Development, and Validation operations as required. The Process Engineer is a hands-on position that will focus on the equipment and processes that support aseptic manufacturing, inspection, and packaging operations.
The Process Engineer will provide Subject Matter Expertise in their area, as well as chair meetings, present topics to the leadership team, and provide constant, thorough, and professional communication to 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.
- Assure compliance with cGMP requirements and adherence to Standard Operating Procedures (SOPs).
- Create and manage the scope of projects.
- Perform Factory Acceptance Testing (FAT) of manufacturing equipment.
- Improve operations for increased quality, productivity, efficiency, and cost savings.
- Investigate operational problems affecting production; report and recommend solutions.
- Identify ways to reduce production costs through recommendations (i.e. new process equipment, equipment justification to improve performance).
- Ongoing strategic evaluation of the existing product portfolio with the objective of optimizing profitability through product modification, supply base management/alignment, and Supply Chain Methods improvement.
- Ability to successfully assemble, lead, and manage a cross-functional value analysis team demonstrating an ability to deliver site and corporate savings goals.
- Provide key performance indicator data (i.e. production control charts, reliability, process capability), to improve the process and monitor and measure progress to target.
- Support new production and development equipment through vendor activities during installation, commission, and qualification activities (I/O/PQ).
- Closely interact with the maintenance technicians to develop, implement, and improve maintenance practices and procedures.
- Identify, generate, and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations in a cGMP environment.
- Collaborate with other relevant departments to determine estimated costs, run time, cost reduction, and provide feedback via video loops.
- 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.
- Bachelor’s degree in the sciences or engineering, required. Manufacturing Engineering (ME) or Industrial Engineering (IE) degree, preferred.
- Minimum 3 years’ experience in a field related to manufacturing or industrial engineering, required. Pharmaceutical manufacturing, preferred.
- Lean Six Sigma certification, preferred.
- Experience writing technical documentation/protocols (i.e. SOP, NOE, CAPA).
- Experience with computer assisted design software (i.e. MS Project/AutoCAD/Solidworks/Visio), preferred.
- Experience operating parenteral manufacturing equipment, preferred.
- 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 50 pounds.
Expected Salary Range:
$91,000 - $100,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
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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