Process Engineer III

3 days ago

West Chester, Pennsylvania, United States BioSpace, Inc. Full time
Job Title: Process Engineer III

Join our team at BioSpace, Inc. as a Process Engineer III and contribute to the development of innovative biomanufacturing solutions.

About the Role:

We are seeking a highly skilled Process Engineer III to lead the development and implementation of automated manufacturing processes in our regulated production environment. As a key member of our team, you will be responsible for ensuring the technical process is clear, delivering a capable process, and leading continuous process improvement efforts.

Key Responsibilities:
  • Develop and implement automated manufacturing processes in a regulated production environment.
  • Lead continuous process improvement efforts, including changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction.
  • Ensure success criteria for technology transfer and validation are clear and the process is capable for the merge into the Manufacturing/Facility process.
  • Generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/reports.
  • Coordinate and support Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence.
  • Maintain external technical relationships and collaborate with equipment and material suppliers.
  • Identify, develop, generate, and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations.
  • Perform and maintain risk management activities for new and existing processes/equipment.
  • Initiate deviations and perform/facilitate technical investigations and assessment of impacts.
  • Author and review documents, including Standard Operating Procedures, Batch Records, Rework procedures, and other forms.
  • Provide engineering and project management services.
  • Assist in the development of project justification and engineering proposals, including providing input for capital planning process.
  • Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment.
  • Perform routine validation and periodic reviews activities.
  • Support and lead technical trouble shooting.
  • On-call support as required.
  • Key contact for regulatory inspections as technical process owner.
  • Participate in annual product review process.
  • Participate in biennial critical systems review process.
Requirements:
  • Experience in GMP or regulated production environment.
  • Training or experience in applicable technologies, including mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics.
  • Proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.
Preferred Qualifications:
  • Bachelor's Degree in Engineering or related science.
  • Project management.
  • Uses their insight to challenge and adapt current approaches/ways of doing things.
  • Experience in Six Sigma/analytical trouble shooting skills.
  • Experience working in a LEAN manufacturing environment.
  • Expertise in more than one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.
  • Ability to coach and mentor peers.
  • 4 to 11 years' experience.
About BioSpace, Inc.:

BioSpace, Inc. is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws.

BioSpace, Inc. offers employees a robust total rewards program, including equity, an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package that supports employees with great healthcare, family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement, and support for caregiving needs.

Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills, and knowledge.

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