Sr. Validation Engineer

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 Sr. Validation Engineer is a hands-on senior level engineering position providing Engineering/Quality leadership support to the manufacturing production area including qualifying new equipment, validating production and inspection processes, and managing continuous process improvements.

MAJOR DUTIES OF POSITION:

• Manage the site validation life cycle documentation such as Factory Acceptance Testing (FAT), Characterization, Installation Qualifiaction (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Cleaning Validation (CV), cleanroom validation and Process Performance Qualification (PPQ)
• Manage and maintain the site Validation Master Plan (VMP)
• Provide change evaluation and impact of any changes on the site validation system. Key member of the change review board for the site
• Manage, develop, implement and maintain the site inspection system
• Investigate and procure state-of-the-art manufacturing equipment for manufacturing process improvement
• Implement validation protocols for existing equipment, test method validations and Gage R&R
• Provide expertise in the successful executing of Corrective and Preventive Actions (CAPAs)
• Ensure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating Procedures
• Partner with Quality to maintain and update InnFocus Risk Management files
• Provide manufacturing summary reports for Board and Management Review Meetings
• Collaborate with QA and R&D on the qualification of current and future suppliers
• Partner with the manufacturing supervisor to efficiently meet production forecast through the implementation of effective workstreams and procurement/qualification of new tooling
• Mentor junior engineers in the development of validation protocols for process validation and the application of statistical analysis and techniques
• Provide technical troubleshooting expertise when required

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Minimum of a B.S degree in Engineering or Biological Science, preferably in Mechanical or Biomedical Engineering
• Minimum of 7 years of experience in Manufacturing/Engineering/Quality environments, with at least 5 years in the medical device industry (preferably ocular device)
• Working knowledge of QSR, cGMP, ISO 14971 and ISO 13485
• Hands-on experience in medical device manufacturing and working on CAPAs
• Hands-on experience writing and executing validation protocols (Characterization, IQ, OQ, PQ, CV, TMV and PPQ)
• Ability to interface with regulatory bodies to present technical information
• Understand basic applied statistics, statistical sampling plans, and statistical process control
• Have knowledge of advance statistical methodologies such as DOE
• Have hands-on experience in CAD package such as Solid Works
• Ability to perform tolerance stack-up analysis
• Experience in the development and interpretation of SOPs, Work Instructions (WIs) and engineering drawings
• Strong computer skills in the MS office products
• Ability to work effectively in a team environment
• Excellent technical writing skills

LIMITATIONS AND DISCLAMER:

The above job description is meant to describe the general nature and level of work to be performed; it is not intended to be an exhaustive list of all responsibilities, duties and skills required for the position. Employee will be required to follow other job-related instructions and to perform other job-related duties requested by the manager in compliance of Federal and State laws.

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