Pharma Validation Engineer

3 weeks ago

Rocky Mount, United States Experis Full time

Our client, pharmaceutical manufacturing client is seeking a Validation Engineer to join their team.
 

Job Title: Validation Engineer
Location: Rocky Mount
Pay Range: $35- $65/hr depending on experience 
Duration: Contract (potential to extend/convert)

 

What’s the Job?

  • Serves as validation representative for laboratory instruments and partnering with the laboratories, quality system administrators, digital, instrumentation and quality engineering on implementing new instruments at the site
  • Authors cGMP risk assessments, user requirements & functional specifications, validation plans, validation protocols (i.e., IQ, OQ, PQ), traceability matrices, summary reports, addendums, decommissioning protocols, and other validation deliverables as required by the site validation SOPs
  • Initiates and leads risk assessment, gap analysis and deviation management for commissioning of changes to or decommissioning of laboratory instruments and associated instrument control software
  • Ensures lab instruments adherence to national and international regulatory guidelines on electronic records and electronic signatures and data integrity, cGMP, FDA 21 GFE Part 11/210/211 EU Annex 11 and MHRA guidelines.
  • Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence.
  • Assists system owner with evaluating and recommending the appropriate user roles and privileges for data integrity and with the writing of instrument operation instructions

What’s Needed?

  • HS diploma with 6 yrs experience or associates degree with 4 yrs experience or bachelors degree with 1 yr experience
  • Experience validating a variety of lab instruments including atomic absorption (AA) spectrometer, dimensional measurement systems, genetic analyzer, FT-IR, IC, ICP-MS, particle counter, TOC, UV/VIS, and universal testing (tensile and compression) machines within various labs (biological, chemical, environmental monitoring, etc)
  • Exposure to lab operations and scientific processes associated as well as familiarity with a variety of lab instruments within various areas
  • Good working knowledge of DA regulations/guidance and GMP
  • Understanding of global regulations on data integrity including FDA Title 21 Part 11

What’s in it for me?

  • Health, Dental, Vision, 401k
  • Weekly pay with direct deposit
  • Consultant Care

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you

 

About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

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