Validations Engineer

Responsibilities

• Develop and execute validation protocols associated with new products, equipment, systems, and processes used in the FISI facility.
• 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 compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements, as applicable.
• Ensure that Validation management is notified of deviations from protocol criteria, support the identification of root causes and resolutions.
• Support the investigation of deviations and problem-solving activities to identify root cause(s).
• Cover the scheduling of protocol execution and testing with affected departments and personnel, including but not limited to: Manufacturing, Quality Assurance/Control, R&D and Facilities.
• 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.
• Support the development of project plans and timelines.
• Work within cross-functional teams.
• May be required to perform other duties as assigned or as needed by Validation Manager.

Requirements

• BS in Bioengineering, Chemical Engineering, or equivalent.
• A minimum of 2+ years performing equipment/process/facility qualifications/validations in a medical device, pharmaceutical, or food manufacturing industry.
• Process Engineering and Manufacturing Engineering experience beneficial.
• Knowledge of study design (e.g., DOE).
• Knowledge of process validation, cleaning validation, and computerized system validation.
• Knowledge of equipment/system/facility qualification.
• Knowledge of FDA/cGMP/QSR and associated guidelines relevant to validation.
• Ability to speak, read, and write English proficiently.
• Proficient oral and written communication skills.

Qualifications

Salary And Benefits: For California, the base salary range for this position is $ 106,185.25 - $115,000. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

Benefits: Medical, Dental, Vision, Life Insurance, 401k, Paid Time Off.

Skills

• Equipment/system/facility qualification.
• Computerized system validation.
• Process validation.
• Cleaning validation.
• Study design (e.g., DOE).
• FDA/cGMP/QSR guidelines.

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401k
• Paid Time Off

Pay

$ 106,185.25 - $115,000

Schedule

N/A