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Req Id 7201 Posted 05/04/2011 Job Description Print Preview ApplySave JobEmail Job to FriendReturn to List DRS Defense Solutions, LLCis a bestinclass developer ...
for one Process Validation Engineer to support one of... process validation protocols Execute process validation protocols Generate Process Validation Final......
For your reference, we have included the original job posting below.
Validation Engineer
Job Number:
26848293
Company Name:
Dendreon
Job Location:
Seal Beach, CA US
Job Categories:
Science & Biotech Engineering & Architecture
Salary:
Neg
Minimum Education:
4-Year College Degree
Validation Engineer
Categories: Life Sciences, Science/Biotech Technicians
Validation Engineer Validation Department Seal Beach, California
Dendreon is seeking a skilled Sr. Validation Engineer I to provide monthly updates on the validation compliance level of our Seal Beach, CA site, lead the validation contractors, and work with Facilities on equipment enrollment and schedules for validation executions. The successful candidate will join a motivated and hard-working QA team in working with a product that will dramatically alter the therapy of prostate cancer.
Job Description: Participates in the development, implementation and adherence to validation test procedures (equipment, utilities, cleaning, and process) ensuring product(s) meet appropriate regulatory agency validation requirements, internal company standards and current industry practices. This may include some of the following:
Prepares and reviews validation protocols and final reports (IQ, OQ and PQ). Develops and revises standard operating procedures (SOPs). Assists with equipment selection and specification. Coordinate the proper approval of plans and protocols. Develop training and ensure implementation of validation execution training. Act as subject matter expert during regulatory inspections or audits. Monitors validation change control and/or corrective actions. Lead contract validation consultants and validation execution by third party. Represents department in cross functional teams, projects and GXP related problem resolution. Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
Requirements:
Bachelor?s degree in a scientific or engineering discipline or equivalent. Typically 5 years related experience in cGMP/FDA regulated industry. Knowledge of cGMP/QSR and FDA device/drug/biologics regulations. Proficient in MS Word, Excel, Outlook and Project. Excellent written and verbal communications skills. Extremely detail oriented with a focus on quality and metrics. Flexible and able to work in a team environment.
Working Conditions & Physical Requirements:
Ability to gown aseptically for work in Clean Room environments. May be required to work alternate shifts. Some travel may be required.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.
