successfactors
Process Engineer
Datwyler Group
Middletown, USA
Mid · 5+ years experience
Onsite
Discovered 2 weeks ago
sap
Key Skills for This Role
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Full Job Posting
Requirements
- A Bachelor's degree in Chemical, Mechanical, Biomedical, or a related engineering discipline Knowledgeable about washing processes Effective communication skills both verbal and written 5+ years of experience in a process engineering role, ideally in a regulated manufacturing environment (pharmaceutical, medical device, chemical or biotech under cGMP preferred). Working knowledge of high-purity water systems (PW, WFI, clean steam) and the USP requirements behind them Strong understanding of validation principles and regulatory compliance. Strong problem-solving skills and hands-on experience with manufacturing equipment and systems. Excellent communication and collaboration skills in a cross-functional team environment. Experience washing primary packaging components (stoppers, plungers, seals) or other parts for parenteral use is a plus Familiarity with endotoxin and particulate test methods is a plus Experience with clean room processing is preferred. Experience with general manual & automated manufacturing practices such as mixing, pumps & process piping, chemical dosing, and automated parts feeding & inspection systems, etc. is preferred. Exposure to Lean, Six Sigma, or other continuous improvement methodologies Familiarity with manufacturing systems such as MES, SAP, MII, etc. Willingness to travel up to 25%, beyond the two sites, including customer visits, other Datwyler sites, training, and equipment vendors for FATs Be yourself at Datwyler We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas. www.datwyler.com
Preferred Qualifications
- A Bachelor's degree in Chemical, Mechanical, Biomedical, or a related engineering discipline Knowledgeable about washing processes Effective communication skills both verbal and written 5+ years of experience in a process engineering role, ideally in a regulated manufacturing environment (pharmaceutical, medical device, chemical or biotech under cGMP preferred). Working knowledge of high-purity water systems (PW, WFI, clean steam) and the USP requirements behind them Strong understanding of validation principles and regulatory compliance. Strong problem-solving skills and hands-on experience with manufacturing equipment and systems. Excellent communication and collaboration skills in a cross-functional team environment. Experience washing primary packaging components (stoppers, plungers, seals) or other parts for parenteral use is a plus Familiarity with endotoxin and particulate test methods is a plus Experience with clean room processing is preferred. Experience with general manual & automated manufacturing practices such as mixing, pumps & process piping, chemical dosing, and automated parts feeding & inspection systems, etc. is preferred. Exposure to Lean, Six Sigma, or other continuous improvement methodologies Familiarity with manufacturing systems such as MES, SAP, MII, etc. Willingness to travel up to 25%, beyond the two sites, including customer visits, other Datwyler sites, training, and equipment vendors for FATs Be yourself at Datwyler We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas. www.datwyler.com
About Datwyler Group
Medical Device Manufacturing7919 employeesFounded 1915
Public Swiss manufacturer of system-critical elastomer components for pharmaceutical, automotive, industrial, and food-and-beverage customers.
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