Validation Engineer II
Job Type:
Regular Full-Time
Location:
Morris Plains, NJ
Job Description:
Dendreon is seeking skilled Validation Engineers to perform validation functions including protocol generation and execution, risk assessments and validation impact assessments to maintain a high level of compliance with GMP equipment and systems. The successful candidates will join a motivated and hard-working New Jersey QA team in working with a product that will dramatically alter the therapy of prostate cancer.
General Summary:
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 one or more of the following:
Writes validation protocols and final reports (IQ, OQ and PQ).
Documents and reviews standard operating procedures (SOPs).
Coordinates the proper approval of plans and protocols.
Mentors new team members and assists in the training of validation execution.
Supports regulatory inspections or audits.
Tracks and coordinates validation change control and/or corrective actions.
Serves as information resource for validation technicians, contractors and vendors.
Represents department in cross-functional teams, projects and GXP-related problem resolution.
Job Requirements:
Bachelor’s degree in a scientific or engineering discipline or equivalent.
Typically 2 years related experience in cGMP/FDA regulated industry.
Proficient in MS Office applications.
Working Conditions and Physical Requirements:
Ability to gown aseptically for work in Clean Room environments.
May be required to work alternate shifts.
Some travel may be required.
Must be able to lift 40lbs.
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.