Process Development Engineer II — NPI & Optimization

Werfenlife SA.; Bedford, Northern (MA, KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Paid vacation

Job summary

Werfen is seeking an engineer to support process development, validation, and platform initiatives in Bedford, MA. You will plan and execute IQ/OQ/PQ studies, analyze data, and collaborate with cross-functional teams to implement new designs and technologies.

With a BS in Engineering and at least 2 years of related experience, you will contribute to continuous improvement while ensuring compliance with quality and regulatory requirements. The role is on-site in Massachusetts.

Qualifications

• B.S. in Engineering and at least 2 years of related experience or equivalent education/experience.
• Experience with validation under IQ/OQ/PQ and process qualification.
• Ability to perform characterization studies and data analysis.

Responsibilities

• Perform validation activities including IQ, OQ, PQ and evaluate operating conditions.
• Review risk documents such as pFMEAs and support risk analysis.
• Carry out varied engineering assignments with limited supervision and guidance.
• Provide technical direction to support personnel as directed by supervisor.
• Design and develop moderately complex parts, components, or circuits.
• Prepare specifications for developed parts and circuits.
• Maintain engineering notebooks and document results clearly.
• Collaborate with cross-functional teams to support new designs and platform tech.

Skills

Validation activities

IQ/OQ/PQ

Process characterization

Engineering analysis

Education

B.S. in Engineering

Job description

Werfen is seeking an engineer to support process development, validation, and platform initiatives in Bedford, MA. You will plan and execute IQ/OQ/PQ studies, analyze data, and collaborate with cross-functional teams to implement new designs and technologies.

With a BS in Engineering and at least 2 years of related experience, you will contribute to continuous improvement while ensuring compliance with quality and regulatory requirements. The role is on-site in Massachusetts.