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21 days old

LIMS Software Validation Manager

Kelly Services
Glendale, CA 91222
_Kelly Technology_ is helping its client, a LIMS technology company finding a **_LIMS Software Validation Manager._**


Its an urgent need.


**_LIMS Software Validation Manager_**


_Location: REMOTE (anywhere in US)_


_Client Industry: Bopharma_


_Direct Hire. Flexible work schedule_


Competitive total compensation packages (salary base plus shares)


We are looking for an experienced Software Validation Manager to ensure that software product meets all necessary GxP requirements.


The **_LIMS Software Validation Manager_** will help oversee the Good Manufacturing Practices (GMP) software testing lifecycle for the software development program, including automated testing.


Create, review approve CSV deliverables such as, UserFunctional Specification, Design specification, IQOQPQ qualifications.


High level responsibilities include overseeing test case creation, documentation, and execution, including GMP software validation.


Qualification protocols execution and final report view and approval for LIMS projects


Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects Work independently but recognize the need to consult stake holders and keep them informed of progress.


In addition, the Manager will oversee a team of testers executing test cases, drafting test plans, implementing improvements to the testing procedures (including and standard operating procedures or SOPs), and liaising between quality, development, and client-facing implementation teams.


**KNOWLEDGE/EXPERIENCE/SKILLS**


Advanced knowledge and expertise in Computer System Validation, FDA international requirements and Part 11 requirements.


Minimum of 3-5 years of experience working on any LIMS or MES or Lab IDM or EMS application development and GMP pharmaceutical biotechnology medical device environment. Ability to master technical content through interaction with subject matter experts.


Effective communication and interpersonal skills.


Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.


Understanding of programming and relational database concepts is required.


Detail oriented script writing abilities


A degree related to technical writing e.g. biology, chemistry, computer science and/or technology disciplines is preferred


_Interested in this role? Please feel free to reach out directly_


_Tina Zahradnik, PHR_


_Senior IT Recruiter, Kelly Technology_


tina.zahradnik@kellyit.com _or 720-315-1387_


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


By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.


**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-05-28 Expires: 2021-06-28

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LIMS Software Validation Manager

Kelly Services
Glendale, CA 91222

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