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Validation Engineer - 3rd Shift

Kelly Services

Brooklyn Park, MN
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Validation Engineer - 3rd Shift

Jobid US41L8DV_BH1433165

Location: Brooklyn Park, MN, 55443, USA

Description **Job Details:**

**Industry:** Pharmaceutical

**Work Location:** Brooklyn Park, MN

**Job Title:** Validation Engineer – 3rd Shift

**Duration:** 10 Months (Temporary/Contract) with potential contract extension
**Validation Engineer** **_–_** **Brooklyn Park, MN**

Kelly Services is currently seeking a **Validation Engineer** **_– 3rd Shift_** for one of our top clients in **Brooklyn Park, MN.**



**Validation Engineer**

On-Site Brooklyn Park only; Local only
Shift 8 PM - 6 AM with some weekends (rotating)

This is a 10 month temp position, with potential for contract extension, working night shift (evenings/weekends).
As a **Validation Engineer** , you will be responsible for assisting the validation department in execution and review of cleaning development and verification documentation. This documentation shall be comprised of cleaning development/verification protocols that have been executed after post batch cleaning (CIP and COP). This documentation shall also include lab and monitoring data that confirms the effectiveness of the cleaning process.
**Additional Job Responsibilities:**
• Attend shift change meetings to coordinate study execution under supervision of Validation Team Lead.
• Reviews cleaning development test records for accuracy and compliance with the company cleaning validation program and Good Documentation Practices (GDP).
• Review lab results for cleaning studies against protocol requirements and document results in cleaning development test records.
• Generate deviations for failed cleaning studies.
• Assemble binders with documentation from multiple departments for final archiving.
• Track documentation and open items.
• Interface with multiple departments to perform document corrections.
**Job Requirements:**
• Bachelor’s degree, or Associates degree with relevant experience is preferred.
• 1+ years of Pharmaceutical manufacturing industry or regulated laboratory experience. Medical device experience may also be considered.
• Must be able to clearly speak, write, read, and understand English. Including the ability to understand and verify scientific text and data.
• Strong organizational skills, with the ability to handle multiple tasks.
• Strong attention to detail.
• Good oral and written communication skills, with the ability to interact appropriately with various groups including QA, QC, Technical operations, manufacturing and engineering.
• Ability to work weekends as needed.
**Desired Experience, Skills and Abilities:**
• Experience with data review and/or auditing in a GLP or GMP environment. Cleaning verification/validation experience in Biotech or Parenteral industry would be a plus.
• Working knowledge of Biotech/Parenteral manufacturing, laboratory procedures, scientific testing standards, good documentation practices and concepts regarding validation and qualification.
• The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

**Why Kelly?**
As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies
+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career
+ Access to more than 3,000 online training courses through our Kelly Learning Center
+ Weekly pay and service bonus plans
+ Group-rate insurance options available immediately upon hire*
**Apply Today!**

**Important information:** This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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