Process Engineer – 24/7 Washing & Validation (Regulated)

Datwyler; City of Middletown (NY); On-site; USD 100,000 - 150,000; Full time

Job summary

Datwyler is seeking a Process Engineer to lead washing processes ensuring regulatory compliance and on-time delivery across two sites (Pennsauken, NJ and Middletown, DE). You will drive cycle development, re-qualification programs, and validation master plans while improving process efficiency and product quality.

The role requires 5+ years in regulated manufacturing (pharma/medical device or chem/bio), strong problem-solving, and travel up to 25%.

Qualifications

• Bachelor's degree in Chemical, Mechanical, Biomedical, or related engineering discipline.
• Familiarity with washing processes and high-purity water systems (PW, WFI).
• Strong knowledge of validation and regulatory compliance.
• Excellent written and verbal communication; cross-functional collaboration.

Responsibilities

• Create and execute User Requirements for the process, including validation documents.
• Validate new designs and re-qualification practices; develop cycle development plans.
• Analyze test data and define validation strategies; maintain preventative maintenance plans.

Skills

Process engineering

Regulatory compliance

Validation principles

Cross-functional teamwork

Troubleshooting

Education

Bachelor's degree in engineering

Tools

MES

SAP

MII

Job description

Datwyler is seeking a Process Engineer to lead washing processes ensuring regulatory compliance and on-time delivery across two sites (Pennsauken, NJ and Middletown, DE). You will drive cycle development, re-qualification programs, and validation master plans while improving process efficiency and product quality.

The role requires 5+ years in regulated manufacturing (pharma/medical device or chem/bio), strong problem-solving, and travel up to 25%.