Kelly Services Technical Writer, Biologics & Manufacturing V in Brooklyn Park, Minnesota
Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Technical Writer, Biologics Manufacturing at a prestigious Fortune 500® company working in Brooklyn Park, MN.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.
Job Title: Technical Writer, Biologics Manufacturing
Pay: $50 per hour depending on experience
Position Summary :
The Technical Writer will be supporting Manufacturing Validation efforts at Brooklyn Park, with a predominant focus on the Cleaning Validation Program, but potentially also supporting the Sterilization Validation program (or other validation programs), as bandwidth allows.
Technical Writer with a background in Biologics or Pharmaceutical Manufacturing. This is a 12 month contract position, with typical working hours of Mon-Fri 8:30-5:00pm. Occasional weekend work or flex scheduling coverage for team members may be required to help meet team deadlines.
As a Technical Writer supporting Biologics Manufacturing, you will be responsible for assisting the validation department in producing technical documents to support the site’s cleaning validation program, with support for other validation programs (example: sterilization validation, shipping validation, etc.), as time permits. Technical documents within the scope of this responsibility will include development reports, validation protocols, validation reports, and other technical assessments to support QMS documentation (deviations, change controls, CAPAs, etc.).
Additional Job Responsibilities
• Attend cross-functional meetings (Validation, Manufacturing, Engineering, QC, QA) to capture/interview functional feedback for inclusion in technical documentation.
• Interact with sample coordinators and/or QC lab to capture analytical data for inclusion in technical documentation.
• Assist with review of executed technical protocols and/or test records for accuracy and compliance with the company’s validation program and Good Documentation Practices (GDP).
• Utilize internal archives (electronic and paper) to research/cite supporting information for authoring and/or review of technical documents.
• Review lab results for cleaning studies against protocol requirements and document results in cleaning development test records.
• Facilitate cross-functional reviews, feedback, comment resolution, and approvals for technical documentation against program timelines.
• Bachelor’s Degree, or Associate Degree with relevant technical writing experience is preferred.
• 2+ years of Pharmaceutical or Biologics 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.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com at http://www.kellyservices.com/ .
Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
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 2016 was $5.3 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm