Manufacturing Engineer
Share
Job Location:
Santa Clara County, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
24-10-2025
Vacancies:
1 Vacancy
Job Summary
The Senior Manufacturing Engineer will lead and manage projects within filling and packaging manufacturing streams. This role focuses on defining equipment specifications improving process efficiency reducing downtime and supporting automation initiatives to ensure compliance quality and operational excellence in a cGMP environment.
Responsibilities
Plan design and implement new manufacturing equipment and packaging processes.
Lead cross-functional project teams to meet cost quality and performance goals.
Support equipment qualification (IQ/OQ/PQ) testing and validation activities.
Develop and maintain manufacturing documentation including SOPs and process records.
Identify opportunities for process optimization automation and cost reduction.
Ensure compliance with cGMP ISO and FDA regulations.
Required Skills
Bachelors degree in Engineering or related field.
56 years of experience in a cGMP manufacturing environment with automated filling and packaging systems.
Strong knowledge of equipment qualification (IQ/OQ/PQ) and process validation.
Proven ability to manage multiple projects in a matrixed organization.
Excellent analytical troubleshooting and communication skills.
Preferred Skills
Masters degree in Engineering or related discipline.
Experience with automation surface treatments adhesive bonding microdispensing and injection molding.
Familiarity with medical device or diagnostics manufacturing and design transfer activities.
Knowledge of Material Science and continuous improvement methodologies.
Required Skills:
Process Engineering Validation
Company Industry
IT Services and IT Consulting
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
