Kelly Services Validation Engineer - 3rd Shift in Brooklyn Park, Minnesota
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.
MUST BE AVAILABLE FOR NIGHT SHIFT 3RD SHIFT HOURS ONLY 8 PM to 6 AM
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.
• 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.
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*
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 in
industry leading organizations. Top companies throughout the world have trusted Kelly as a premier
source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm
with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety
and flexibility of working on short term project engagements, or prefer contract-to-hire or direct
hire placement with our clients, apply with Kelly to explore opportunities that suit your specific
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 kellyservices.com 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 is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.