BioSpace
Process Engineer III, Electromechanical (Night Shift)
BioSpace, West Chester, Ohio, United States
Process Engineer III, Electromechanical (Night Shift)
BioSpace
Position Summary & Responsibilities
Ensures there are two technical processes (i.e., Prep and filling) with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process
Leads continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for automated pharmaceutical manufacturing equipment
Ensures success criteria for technology transfer and validation are clear and the process is capable for the merge into the Manufacturing/Facility process
Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/reports
Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, efficiencies, and obsolescence, managing the life cycle of assets
Maintains external technical relationships and collaborates with equipment and material suppliers
Identifies, develops, generates, and manages implementation of appropriate change controls to improve processes and address root causes identified in investigations
Performs and maintains risk management activities for new and existing processes/equipment
Initiates deviations and facilitates technical investigations and assessment of impacts
Authors and reviews documents including Standard Operating Procedures, Batch Records, rework procedures, and other forms; author, review, and approve validation and change control documents such as master plans, protocols, summary reports, and change requests
Provides input and develops user requirements for new asset procurement
Provides engineering and project management services
Assists in the development of project justification and engineering proposals, including capital planning input
Identifies and supports technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
Performs routine validation and periodic review activities
Supports and leads technical troubleshooting
Provides on‑call support as required
Acts as key contact for regulatory inspections as technical process owner
Participates in annual product review process
Participates in biennial critical systems review process
Responsible for process validation required as a result of changes to validated processes within Manufacturing
Minimum Qualifications
Experience in GMP or regulated production environment
Training or experience in applicable technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical troubleshooting, 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 experience
Ability to challenge and adapt current approaches/ways of doing things
Experience in Six Sigma/analytical troubleshooting 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 in an engineering role
Resilience 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. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package thoughtfully designed to support employees with healthcare (medical, dental, vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement, and support for caregiving needs.
Salary range: $80,000.00 – $121,250.00 per year.
#J-18808-Ljbffr
Position Summary & Responsibilities
Ensures there are two technical processes (i.e., Prep and filling) with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process
Leads continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for automated pharmaceutical manufacturing equipment
Ensures success criteria for technology transfer and validation are clear and the process is capable for the merge into the Manufacturing/Facility process
Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/reports
Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, efficiencies, and obsolescence, managing the life cycle of assets
Maintains external technical relationships and collaborates with equipment and material suppliers
Identifies, develops, generates, and manages implementation of appropriate change controls to improve processes and address root causes identified in investigations
Performs and maintains risk management activities for new and existing processes/equipment
Initiates deviations and facilitates technical investigations and assessment of impacts
Authors and reviews documents including Standard Operating Procedures, Batch Records, rework procedures, and other forms; author, review, and approve validation and change control documents such as master plans, protocols, summary reports, and change requests
Provides input and develops user requirements for new asset procurement
Provides engineering and project management services
Assists in the development of project justification and engineering proposals, including capital planning input
Identifies and supports technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
Performs routine validation and periodic review activities
Supports and leads technical troubleshooting
Provides on‑call support as required
Acts as key contact for regulatory inspections as technical process owner
Participates in annual product review process
Participates in biennial critical systems review process
Responsible for process validation required as a result of changes to validated processes within Manufacturing
Minimum Qualifications
Experience in GMP or regulated production environment
Training or experience in applicable technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical troubleshooting, 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 experience
Ability to challenge and adapt current approaches/ways of doing things
Experience in Six Sigma/analytical troubleshooting 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 in an engineering role
Resilience 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. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package thoughtfully designed to support employees with healthcare (medical, dental, vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement, and support for caregiving needs.
Salary range: $80,000.00 – $121,250.00 per year.
#J-18808-Ljbffr