Sr Validations Engineer

FUJIFILM Holdings America Corporation; Santa Ana (CA); On-site; USD 103,000 - 135,000; Full time

Job summary

An established industry player is seeking a Sr. Validations Engineer to enhance their validation processes. This role involves developing and executing validation protocols, leading qualification efforts, and ensuring compliance with FDA and cGMP guidelines. The ideal candidate will have over six years of experience in the medical device or pharmaceutical industry, with a strong background in validation protocols and root cause analysis. Join a forward-thinking company dedicated to advancing healthcare initiatives through innovative solutions and quality assurance.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401k

Paid Time Off

Qualifications

• 6+ years in validation for medical devices or pharmaceuticals.
• Proficiency in validation protocols and FDA guidelines.

Responsibilities

• Develop and execute validation protocols for new products and processes.
• Lead qualification/validation protocols and analyze validation data.

Skills

Validation Protocols

Root Cause Analysis

Process Validation

Equipment Qualification

FDA/cGMP Guidelines

Education

BS in Bioengineering

BS in Chemical Engineering

Tools

SAP

Job description

Position Overview

We are hiring a Sr. Validations Engineer. The Sr. Validations Engineer will be responsible for performing validation activities related to processes, equipment, test methods, computerized systems, and facilities.

Company Overview

FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assistcustomers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicineand cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company istrusted by researchers, manufacturers, and cliniciansworldwide.For over 50 years, FUJIFILM Irvine Scientific’sMission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in itsproducts and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’sfacilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization centerin China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability ValuePlan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

Job Description

Responsibilities

• Develop and execute validation protocols associated with new products, equipment, systems, and processes used in the FISI facility.
• Lead and support the execution of qualification/validation protocols (IQ/OQ/PQ/PV/CV/CSV), including the collection of samples, data, and completion of protocols.
• Directly and indirectly compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements, as applicable.
• Ensures that Validation management is notified of deviations from protocol criteria, supports the identification of root causes and resolutions.
• Support the investigation of deviations and problem-solving activities to identify root cause(s).
• Coordinates the scheduling of protocol execution and testing with affected departments and personnel. This includes, but is not limited to: Manufacturing, Quality Assurance/Control, R&D and Facilities.
• Lead and support the creation and review of SOPs.
• Train equipment operators or other staff on qualification/validation/study protocols and standard operating procedures, as required.
• Support the execution of commissioning protocols such as Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT), as applicable.
• Lead and support the development of project plans and timelines.
• Lead and support the tracking of project goals and work within cross-functional teams.
• Provide guidance to the Validations Specialist(s) and oversee their activities, as requested.
• May be required to perform other duties as assigned or as needed by Validation Manager.

Required Skills/Education

• BS in Bioengineering, Chemical Engineering, or equivalent.
• A minimum of 6+ years performing equipment/process/facility qualifications/validations in a medical device, pharmaceutical, or food manufacturing industry.
• 4+ years in a relevant validation role.
• Process Engineering and Manufacturing Engineering experience beneficial.
• Proficiency in Validation Specialist Level I and II functions.
• Experience with SAP highly preferred.
• Knowledge of study design (e.g., DOE).
• Advanced knowledge of process validation, cleaning validation, and computerized system validation.
• Advanced knowledge of equipment/system/facility qualification.
• Knowledge of FDA/cGMP/QSR and associated guidelines relevant to validation.

Salary and Benefits:

• For California, the base salary range for this position is$103,093- $134,204. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

*#LI-onsite

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).