Grifols Shared Services North America, Inc Validation Engineer in Los Angeles, California
Responsible for conducting validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes.
Essential Job Duties:
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 time lines. Assists in the development of the time lines 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.
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.
This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned, and qualifications required may change over time.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 163408