Senior Process Manufacturing Engineer

Pagedale, Missouri, United States
The Senior Process Manufacturing Engineer in our St. Louis, MO location is responsible for establishing themanufacturing process capability for new/reformulated products. In this role you will support the execution ofequipment qualification, cleaning, and process validation program. Prepare and revise batch records, operatinginstructions, and cleaning instructions. Conduct process improvement studies in the areas of operationalproductivity, process control, quality processing, employee safety, process yield improvement, and environmentalimpact in a lean environment. Test new technologies, processes, controls or prototype equipment and supportimplementation as appropriate to optimize liquid blending systems. Provide indirect supervision of technicians,interns and operators as required. Develop P&ID’s in support of validation efforts. Develop design of experiment(DOE) for the purpose of scale-up, troubleshooting and modifications of new and existing processes.
This position requires that you work onsite Monday through Friday during core business hours in our St. Louis, MO location.
What You'll do as a Senior Process Manufacturing Engineer
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 andintroduction of new/reformulated products.
Interface with Product Development and Production to bring these processes from the research laboratorythrough scale-up full-scale manufacturing.
Responsible for research and testing of new technologies or processes appropriate for support ofnew/existing product manufacture.
Establish and maintain set point controls.
Support Project Engineering to obtain approval for Capital Appropriation Requests, design specifications andequipment installation.
Provide personnel training, development of manufacturing instructions and start-up of newprocesses/equipment.
Responsible for conducting process studies, identifying opportunities for improvement and supportingimplementation 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, engineeringanalysis, conclusions and recommendations.
Monitor and provide solutions in terms of quality, yields, throughput, cycle times, process parameters, cGMPcompliance, and safety and environmental requirements.
Apply structured, technical problem-solving methodologies such as DMAIC, six sigma green belt/black beltstatistical 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, includingchemical and biological formulation, filling, packaging, and quality operations.
Employ key project management principles including establishing and tracking timelines, identifying andmitigating risks, communicating across teams at all levels.

The Experience, Skills and Abilities Needed
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.

Lean Six Sigma certification such as Green Belt or Black Belt, preferred.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is just a brief overview of what we offer

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
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

Pay range for this opportunity is $92,650.00 - $119,900.00. [ACTION REQUIRED - REMOVE IF NOT APPLICABLE:] This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits:
Open until position is filled.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit .
If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.
Your engaging subtitle goes here. This text should capture attention and provide a brief overview of engaging content that awaits users in this widget.
Get notified for similar jobs
Sign up to receive job alerts
Get tailored job recommendations based on your interests.
Currently we dont have enough information to provide personalized job recommendations.
Directs plant employees and manufacturing supervisors in the resolution of batch record errors as identified during internal review and review by Quality Systems, including but not limited to document...
Take on the role of Product Labeling Specialist, collaborating with cross-functional teams to develop and maintain product packaging and labelling documentation. Ensure compliance with regulatory and marketing requirements. Ideal for candidates with significant experience in medical device labelling and technical document review.
St Louis, Missouri, United States
Exciting opportunity for a Manufacturing Supervisor to lead teams in efficient production of STERIS products. Oversee production schedules, ensure safety and quality standards, and manage logistics for timely material flow. Ideal for candidates with significant production and supervisory experience in a manufacturing environment.