Manufacturing Engineer

Job Description
Our client, a world leader in diagnostics and life sciences, is looking for a "Sr Manufacturing Engineer " based out of Santa Clara, CA.

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

• Bachelor's degree in Engineering or related field.
• 5-6 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

• Master's 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.

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

Interested Candidates please share your resume to View email address on click.appcast.io/View email address on click.appcast.io

Skill Set
Process Engineering, Validation