Manufacturing Process Engineer

Manufacturing Process Engineer

Full-time

Company Description

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss.

Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts.

Job Description

The Manufacturing Process Engineer is a hands-on position providing engineering support to the manufacturing production area including qualifying new equipment, validating production processes, and performing continuous process improvements.

ESSENTIAL DUTIES AND KEY DELIVERABLES :

• Provide engineering support for the polymer manufacturing, extrusion, and compression molding processes.
• Installation and Qualification of new polymer synthesizing bioreactor.
• Designing and testing process upgrades and new process systems to streamline manufacturing.
• Performing risk assessments.
• Create CAD drawings of equipment / tooling.
• Qualification of new controlled area for manufacturing processes.
• Ability to apply appropriate problem-solving techniques for effective root causes analysis and successful corrective action.
• Define production equipment spare parts requirements and manages the purchasing and inventory of spare parts.
• Assess equipment qualification and calibration requirements and prepare equipment documentation, IQ / OQ protocols and IQ / OQ reports, execute IQ / OQ protocols per the Validation Master Plan.
• Ability to troubleshoot and repair production equipment as needed.
• Collaborate with QA and R&D on the qualification of current and future equipment suppliers.
• Ensure that all calibrated items are within limits.

Qualifications

QUALIFICATIONS :

• Bachelor’s degree in engineering, mechanical preferred.
• Minimum of 3 years of experience in manufacturing / development environments in medical device industry
• Experience in qualification and validation activities.
• Strong computer skills in the MS office produces.
• Ability to read and understand technical drawings.
• Working knowledge of QSR, cGMP, and clean room environment.
• Preferred experience in extrusion or polymer processing.
• Hands-on experience with manufacturing equipment.
• Experience in CAD drawing programs (Solidworks).
• Proficient technical writing abilities.

PHYSICAL REQUIREMENTS :

• Capable of lifting at least 50 lb of weight.
• Able to work in an industrial environment.

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments.

We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment.

At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members.

All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin / ancestry, religion, sexual orientation, gender, gender identity / expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

COVID-19 Vaccination Requirement : Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19.

Individuals who choose not to get vaccinated and who receive a job offer must follow Santen’s process for requesting a medical or religious exemption and subsequent accommodation.

Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

All your information will be kept confidential according to EEO guidelines.

For more information about our company and the work experience, please visit and .