Validation Engineer

Job Summary Responsible for conducting validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes. Responsibilities 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, lyophilizers, 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. Assist in the development of the timelines and communicate 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 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. Qualifications Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific/technical discipline is required. Minimum of 2 years direct validation experience in a pharmaceutical, biologics, medical device or FDA related manufacturing facility is required. Requires an 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. Must have 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. Occupational Demands Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 4‑6 hours per day. Frequent hand movement of one hand with the ability to make fast, simple movements of the fingers, hands, and wrists. Ability to make precise coordinated movements of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 25 lbs. Infrequently drives. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Interacts with others, relates sensitive information to diverse groups. Pay and Benefits The estimated pay scale for Validation Engineer role based in California, is $80,000 - $90,000. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Location NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA Equal Employment Opportunity Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. #J-18808-Ljbffr Grifols, S.A