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1+ months

Sr. Manager, Validation Engineer

Kelly Services
San Diego, CA 92108
**Kelly Services is actively recruiting for a Direct Hire opportunity in** **San Diego** **, CA for a** **Sr. Manager, Validation Engineer** **.**


We are looking for a talented Sr. Manager, Validation Engineer to join our Rapid Diagnostics group. You will develop validation strategies and supervise a team responsible for multiple complex validation projects for process, equipment and/or computer validation associated with products produced by the Company.


Responsibilities:


Serves as a principle technical authority overseeing validation activities associated with manufacturing and test equipment, computers, and processes. Serves as the validation authority for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.

Leads multiple sophisticated validation activities across the site.

Manages site Validation Engineering team and hires and manages consultants to ensure resources needs are met to achieve timelines

In conjunction with team and key stakeholders, develops validation strategies and provides strategic plans, timelines, and gantt charts with resourcing and milestones. Develops and writes Master Validation Plans and ensures consistency across multiple MVPs.

Resolves significant validation, product and regulatory issues. Plans and establishes technical communications, document flow, testing requirements, and resources vital to complete the validation of a system.

Provides assessments, reviews, and summaries of current work and develops a strong communication plan out to key stakeholders.

Coordinates validation associated audit activities; establishes rationales and technical defense positions.

Supports systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.

Serves as the key recipient and stakeholder of NPI transfer packages from R&D and ensures new products and processes meet project requirements prior to transfer

Participates as the validation representative in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance and interdepartmental consistency within the validation program.

Assures compliance to all applicable laws by proactively interpreting regulatory and compliance requirements as related to validation.

Maintains current knowledge and serve as a technical resource for emerging trends and technologies.

Coordinates and provides training and/or opportunities for career development of others. Identifies training needs and assists develop training programs.


Education:

Bachelors degree in Engineering, Life Sciences, or other related area of study.



Experience:

8+ years of validation experience within diagnostics or other regulated industry.

Experience with Prochain and Microsoft project preferred.

Project management experience



Knowledge, Skills, Abilities

Excellent communication both written and verbal

Time-management skills

People management



**APPLY NOW!**


\#TJP2022_SPEC


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-07-18 Expires: 2022-09-17

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Sr. Manager, Validation Engineer

Kelly Services
San Diego, CA 92108

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