Manufacturing Process Engineer

AMERICAN REGENT, INC.; Shirley (NY); On-site; USD 91,000 - 100,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

401k matching

Job summary

American Regent, Inc. is seeking a Process Engineer to manage multiple projects in an FDA-regulated environment and to drive continuous improvement across aseptic manufacturing, inspection, and packaging operations.

You will lead cross-functional teams, develop procedures and systems to meet cGMP, and present findings to leadership. The role requires hands-on work on equipment, FAT, and collaboration with maintenance and R&D.

Qualifications

• Bachelor’s degree in the sciences or engineering.
• Manufacturing Engineering (ME) or Industrial Engineering (IE) degree, preferred.
• Minimum 3 years’ experience in 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 CAD 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 SOPs, maintenance schedules, and operating manuals.

Responsibilities

• Assure compliance with cGMP requirements and adherence to 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 new process equipment and equipment justification.
• Strategic evaluation of existing product portfolio to optimize profitability.
• Assemble, lead, and manage a cross-functional value analysis team.
• Provide KPI data to improve processes and monitor progress to target.
• Support new production and development equipment through vendor activities (I/O/PQ).
• Collaborate with maintenance to improve practices.
• Implement change controls to improve processes in a cGMP environment.
• Collaborate with departments to estimate costs and run times; provide feedback.

Skills

cGMP knowledge

SOP writing

Education

Bachelor’s degree in sciences or engineering

Manufacturing Engineering or Industrial Engineering

Lean Six Sigma certification

Tools

MS Project

AutoCAD

Solidworks

Visio

Job description

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

• 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/fmlA.pdf

Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.