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Validation Engineer (ONSITE) at PharmaLex

Validation Engineer (ONSITE)

PharmaLex Bloomington, IN (On Site) Full-Time
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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.


General Description:


We are seeking experienced consultants who can provide support as Validation Engineer for a variety of projects. Each qualified candidate will be responsible for coordinating commissioning, qualification and validation activities across all operational areas and ensuring activities are conducted in a timely manner in accordance with cGMP and appropriate regulatory expectations.


REQUIRES IN-DEPTH KNOWLEDGE AND EXPERIENCE:


  • Uses best practices and knowledge of internal or external business issues to improve products or services
  • Solves complex problems; takes a new perspective using existing solutions
  • Works independently and receives minimal guidance
  • Acts as a resource for colleagues with less experience
  • Competent at risk mitigation for function


TYPICAL MINIMUM EDUCATION AND/OR EXPERIENCE:


  • Bachelor’s degree or higher in STEM discipline
  • Master’s degree or higher preferred
  • 3-5 years of experience in Validation or related discipline
  • 1 year GMP experience required or other regulated industry
  • Must be able to read and understand English-written job instructions and safety requirements.


COMMON CHARACTERISTICS: A validation engineer’s primary duty is to participate in


  • Validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.
  • Responsibilities include coordinating multiple projects, documenting activities via protocols and summary report templates help establish new templates and policies as needed, reviewing facility changes and provide input on re-validation, assessing risks involved in processing steps and related to equipment, developing and/or reviewing validation requirements and design deliverables, partnering with contract validation teams to support and monitor efforts, monitoring validation strategies, ensure polices are followed, conducting validation studies inaccordance with batch records/protocols, and identifying exceptions associated with validation protocol execution.


FUNCTIONAL CHARACTERISTICS: With a strong Process Validation background. Key areas of expertise and an understanding and/or experience with the following are preferred:


  • Technical Transfer
  • Process Control Strategies
  • Validation Master Plans
  • Developing a Process Performance Qualification (PPQ) protocol
  • Executing a PPQ protocol
  • Sampling
  • Mixing Studies
  • Hold Studies
  • cGMP
  • Aseptic processing
  • Client interactions (external and internal)


NOTE: Not open for H1B Visa Holder/1099 work arrangement. Only for candidates open for a W2 work arrangement.


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Job ID: LI16-10440_3408034856

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