Company: Apex Systems
Location: Santa Rosa
Posted on: October 12, 2019
Job #: 1001162
- Author and revise validation plans, protocols, and SOP's
- Oversee protocol execution while coordinating with Method
Development, Validation, Production, QA and QC personnel
- Summarize and evaluate protocol data, including resolution of
discrepancies and exceptions
- Work with Production department to assist in maintaining
quality in production.
- Review or re-qualify equipment, instruments, and facilities to
maintain their validated state as defined by SOPs.
- Present project results and recommendations to department
- Proactively and cooperatively communicate with peers and
management to ensure awareness of progress and issues; recommend
solutions when issues arise
- Maintain and meet the highest standards in quality and
- Follow, understand and comply with SOP's and policies on cGLP's
- Perform any other duties as designated by the Manager,
Technical and Instrumentation or dictated by the needs of the
- Bachelor's degree in engineering or life science and 4 years of
experience in a GMP environment.
- 8 + years of experience in pharmaceutical validation or
equivalent industry experience preferred
- Subject matter expert for the following areas: validation of
software, automation, analytical instruments, or general equipment
- Experience with change management assessments for validated
equipment, systems, and processes.
- Experience with total method validations (TMVs) for LC-MS-MS
Interested applicants can also email resumes to
firstname.lastname@example.org for consideration.
Apex Systems is an equal opportunity employer. We do not
discriminate or allow discrimination on the basis of race, color,
religion, creed, sex (including pregnancy, childbirth,
breastfeeding, or related medical conditions), age, sexual
orientation, gender identity, national origin, ancestry,
citizenship, genetic information, registered domestic partner
status, marital status, disability, status as a crime victim,
protected veteran status, political affiliation, union membership,
or any other characteristic protected by law. Apex will consider
qualified applicants with criminal histories in a manner consistent
with the requirements of applicable law. If you have visited our
website in search of information on employment opportunities or to
apply for a position, and you require an accommodation in using our
website for a search or application, please contact our Employee
Services Department at 844-463-6178-6178.
Keywords: Apex Systems, Santa Rosa , Validation Engineer, Engineering , Santa Rosa, California
Didn't find what you're looking for? Search again!