Sr. Equipment Validation Engineer
Company: Yoh
Location: Los Angeles
Posted on: May 6, 2024
Job Description:
Our client, a global bio-pharmaceutical company, that
specializes in -core therapeutic and business areas, including
gastrointestinal and inflammation, rare diseases, plasma-derived
therapies, oncology, neuroscience and vaccines, is actively looking
to add a Sr. Validation Engineer -to their team. This position will
be on-site in Los Angeles. - Salary: -$85,000-$130,000 Location:
Los Angeles, CA Type: Direct Hire Shift: Monday-Friday:
8:00am-5:00pm - KEY JOB RESPONSIBILITIES: -
- Apply thoughtful understanding of cGXPs, GAMP5 and 21CFR Part
11 (as applicable), relevant SOP curriculum, routine project
procedures, project management, and other training.
- Perform a variety of projects in several areas at the same time
to support manufacturing and engineering.
- Responsible for planning, scheduling, and leading validation
assignments. Must demonstrate planning and coordination.
- Review and change control requests with potential impact to
validated state of validation elements, as applicable.
- Lead and interface with team members (Engineering,
Manufacturing, Regulatory Affairs, Quality Operations, Quality
Validation, Supply Chain, and other technical disciplines) -
- Write protocols and reports, execute validation documents
regarding acceptability to industry standards (GMPs, FDA
Guidelines).
- Guide peers in Validation and Engineering Departments to use
sound, statistically based Quality Engineering approaches in
project, test plans and in analyses of test results.
- Utilize Quality-Engineering tools to problem solve/troubleshoot
and assist in risk analysis.
- Use validation test equipment, such as, Kaye Validator and
Ellabs loggers to support validation activities.QUALIFICATIONS:
- Bachelor's degree in engineering discipline required. Chemical,
Mechanical, Electrical Engineering Degree. 3+ years of related
experience.
- Experience in manufacturing processes and control systems,
cleaning processes, process equipment, facilities and critical
support systems.
- Prior experience interacting with the FDA and other regulatory
agencies.
- Must have experience, proficiency, and leadership in
pharmaceutical/biotech validation elements, including the writing
and implementing of protocols and standard operating
procedures.
- Must be proficient in more than one validation element.
- Must have a comprehension of the operating principles in a cGMP
regulated environment. Hands-on Manufacturing, Engineering and
Technical Service experience.
- Must display a solid technical understanding of the validation
element principles and scheduling a series of project technical and
project management overviews.
- Must be able to lift, push, pull and carry up to 25 lbs.
- In general, you will have a combination of sedentary work and
walking around observing conditions in the facility.
- May work in construction or demolition areasNote: Any pay
ranges displayed are estimations. - Actual pay is determined by an
applicant's experience, technical expertise, and other
qualifications as listed in the job description. - All qualified
applicants are welcome to apply.Yoh, a Day & Zimmermann company, is
an Equal Opportunity Employer. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability, or status as a protected veteran.Visit -to
contact us if you are an individual with a disability and require
accommodation in the application process.
Keywords: Yoh, Fountain Valley , Sr. Equipment Validation Engineer, Engineering , Los Angeles, California
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