Validation Engineer

Grifols

Validation Engineer conducting validation studies for manufacturing systems at Grifols. Ensuring compliance with FDA regulations and industry standards in a healthcare-focused role.

Posted 5/28/2026full-timeLos Angeles • California • 🇺🇸 United StatesJuniorMid-Level💰 $80,000 - $90,000 per yearWebsite

About the role

Key responsibilities & impact

Conduct validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes
Develop qualification and validation protocols for manufacturing systems and equipment such as ultra filtration units, chromatography columns, automation controls, utilities, clean rooms, temperature controlled areas, pasteurizers, lyopholizers, etc.
Execute approved studies and protocols to gather data
Analyze the resulting data and develop the final validation report
Responsible for completion of studies within validation project timelines
Assists in the development of the timelines and communicates project updates within the validation department
Investigate and document all validation related deviations and determine assignable cause
Maintain current knowledge of regulatory and industry standards
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events
Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility
Strict adherence to procedures and practices according to FDA regulations
Strong emphasis on documentation according to FDA regulations
Adhere to departmental corporate safety policies

Requirements

What you’ll need

Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry, or closely related scientific/technical discipline
Minimum of 2 years direct validation experience in a pharmaceutical, biologics, medical device, or FDA related manufacturing facility
In depth understanding of validation, pharmaceutical manufacturing, and laboratory processes/equipment (ultrafiltration, CIP, chromatography, reactor tanks, centrifuges, filter presses, etc.)
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines
Strong technical writing skills
Ability to work independently with minimum supervision
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis
Must be proactive, results oriented, and have strong attention to detail
Self-starter with strong work ethic and the ability to exercise good judgment
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment
Excellent verbal and written communication skills in the English language
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
Must be flexible with working hours/shifts in order to accommodate the 24 hour, 7 day plant operation.

Benefits

Comp & perks

Medical
Dental
Vision
Life insurance
PTO
Paid holidays
401(K) match up to 5%
Tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

validation studiesqualification protocolsvalidation protocolsdata analysistechnical writingpharmaceutical manufacturinglaboratory processescGMPFDA regulationsdocumentation

Soft Skills

organizational skillsanalytical skillsproblem-solving skillsattention to detailinterpersonal skillscommunication skillsindependent workproactiveresults orientedtime management