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Validations Specialist V

Location: Swiftwater, PA, United States
Job Type: Contract
Job Category: Pharmaceutical and Biotech
Job Industry: Pharmaceuticals and Medical Products
Salary: The pay we're offering is $59 - $70 per hour
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The Opportunity

Description

We're looking for a Validations Specialist V, working in Pharmaceuticals and Medical Products industry in 1 Discovery Drive, Swiftwater, Pennsylvania, 18370, United States.

  • Reports, compiling data packs and analyzing data for adherence to established acceptance criteria.
  • Typical processes being developed / validated include mixing, filling, formulation, visual inspection and lyophilization
  • Studies supporting these processes include hold time, CCIT, stability, Part 4 compliance.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

  • Knowledge with formulation process validation, filling process validation and aseptic processing
  • Recent hands on experience executing process validations
  • For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPPs and generate detailed validation protocol requirements and coordinate execution for formulation
  • Demonstrated experience with mixing, dispense and filtration process validation
  • 5-7 years in Process Validation (formulation, filling, visual inspection and/or lyophilization)
  • Performance Qualification, E&L, CCIT and Part 4 compliance
  • Familiar with Extractables/Leachables
  • MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Technical writing abilities
  • Strong root cause analysis skills with cGMP experience
  • Must be proficient in E Doc with a working knowledge of templates, workflows and approval process
  • Proficient in MS Word, Excel, Powerpoint and Outlook
  • Interact well with a diverse group of individuals
  • Self-motivated and willing to be proactive in resolving issues

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply Now

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