STERIS · 7 hours ago
Senior Process Manufacturing Engineer
Mentor, OH
Full-time
Onsite
Senior Level
$91K/yr - $112K/yr
5+ years expSTERIS is a company that provides innovative healthcare and life science product and service solutions. The Senior Process Manufacturing Engineer is responsible for establishing manufacturing process capabilities for new products and supporting equipment qualification and process validation. This role involves conducting process improvement studies, testing new technologies, and providing indirect supervision of technicians and operators.
BiotechnologyHealth CareMedical Device
Responsibilities
Support the execution of protocols to comply with FDA and cGMP requirements for equipment qualification, cleaning and process validations
Responsible for the development of lean culture and institution of lean principles
Develop plans, design experiments, and schedules for establishing manufacturing process capability and introduction of new/reformulated products
Interface with Product Development and Production to bring these processes from the research laboratory through scale-up full-scale manufacturing
Responsible for research and testing of new technologies or processes appropriate for support of new/existing product manufacture
Establish and maintain set point controls
Support Project Engineering to obtain approval for Capital Appropriation Requests, design specifications and equipment installation
Provide personnel training, development of manufacturing instructions and start-up of new processes/equipment
Responsible for conducting process studies, identifying opportunities for improvement and supporting implementation of findings to optimize liquid blending systems
Resolve manufacturing deficiencies through troubleshooting and implementation of corrective actions
Develop and submit written reports including objective, experimental, compilation of data, engineering analysis, conclusions and recommendations
Monitor and provide solutions in terms of quality, yields, throughput, cycle times, process parameters, cGMP compliance, and safety and environmental requirements
Apply structured, technical problem-solving methodologies such as DMAIC, six sigma green belt/black belt statistical analysis, etc. to confirm root causes of problems
Implement corrective and preventative actions to solve root causes and prevent recurrence, reduce variation, and drive improvement in quality and other key KPI’s
Serve as Subject Matter Expert (SME) providing deep technical insights into operations processes, including chemical and biological formulation, filling, packaging, and quality operations
Employ key project management principles including establishing and tracking timelines, identifying and mitigating risks, communicating across teams at all levels
Qualification
Required
Bachelors degree in Engineering
Minimum five (5) years in process engineering or equivalent
Background in biochemical or chemical engineering, or microbiology
Project leadership skills, technical skills, and organization skills required
Experience with FDA, and GMP regulated operations, such as Medical Devices or Pharmaceutical Manufacturing
Good communication skills and interpersonal skills
Proven proficiency in facilitating problem solving and other team-based root cause analysis (RCA)
Ability to generate detailed, high quality technical documentation to capture and communicate designs
Ability to influence team members to perform at exceptional levels
Preferred
Lean Six Sigma certification such as Green Belt or Black Belt, preferred
Benefits
Market Competitive pay
Extensive Paid Time Off and added Holidays
Excellent Healthcare, Dental and Vision benefits
Long- and Short-Term Disability coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add- on benefits / discounts for programs such as Pet Insurance
Tuition Reimbursement and continuing education programs
Excellent opportunities for advancement in a stable long-term career
Company
STERIS
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
10001+ employees
H1B Sponsorship
STERIS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$0.28M2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO
Leadership Team
Daniel Carestio
President and CEO, STERIS
Walter Rosebrough
CEO Emeritus & Senior Advisor
Recent News
2025-11-05
Company data provided by crunchbase