Grifols Shared Services North America, Inc Validation Technician in Los Angeles, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
The Validation Technician will be responsible for supporting Validation Engineers through assistance with testing, protocol execution, and data analysis.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Preform pre and post calibrations of thermal monitoring equipment, place probes, and generate reports and graphs of data.
Maintain calibrated state of thermal mapping equipment. Monitor use and age battery life of wireless loggers.
Collect samples during cleaning, testing and validation. Generate test forms and submit samples to QC.
Perform documentation during protocol execution in support of validation engineer protocols, as assigned.
Assist with ensuring paperwork from other departments is available and complete when required.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Associate degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific/technical discipline is required. Bachelor's degree preferred.
Minimum of 2 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required.
Related validation experience is preferred.
Requires a basic understanding of validation principles and qualification requirements for a range of systems, particularly sterilization systems and aseptic processing.
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
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.
Ability to lift /move up to 25 pounds.
Ability to sit/stand for extended periods - up to four (4) hours at a time.
Manual dexterity to perform all job functions.
Ability to gown and work in an aseptic/clean room environment.
Exposure to toxic/caustic chemicals and biological hazards.
*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.
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.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home