Valeant Pharmaceuticals

Senior Validation Engineer - Process Validation

US-SC-Greenville
Job ID
9763
Pos. Category
Operations
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The Sr. Validation Engineer-Process Validation will be subject matter expert and provide leadership in validation of products and components at the Greenville site.

 

In addition, the Sr. Validation Engineer-Process Validation will lead the Media Fill program (execution schedule and investigations).

 

The Sr. Validation Engineer-Process Validation shall be able to manage consultants and mentor validation engineers and validation technicians.

 

The Sr. Validation Engineer-Process Validation will serve as a backup of the Validation Supervisor, mentoring co-workers, approving protocols, and managing consultants among others

Responsibilities

  • Remain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices.
  • Provide validation requirements, strategy, protocols, execution and final reports for changes impacting validated products and critical process parameters.
  • Oversight of validation activities for R&D trials and new products.
  • Support engineering testing/trials and requirements for final product changes.
  • Creation, review, and update of risk analysis for changes and new processes that impact products.
  • Perform statistical analysis related to process validation.
  • Conduct periodic review of validated processes and equipment.
  • Support product annual product review.
  • Peer review validation studies executed by other validation team members.    
  • Provide inputs in validation and regulatory requirement for current direct impact equipment, new equipment, and processes.
  • Able to self-train in new regulation and industry standards
  • Demonstrate enough knowledge in basic validation skills and the ability to lead change control, approve quality changes request, and other discipline protocols in lieu of the Validation Supervisor, as needed.

Qualifications

  • Required:  FDA Process Validation Guidance, Statistical Sampling, Technical Writing, Use of MiniTab, product validation
  • Desired:  Conducting and leading investigation, project management, Design of Experiments, knowledge in aseptic simulation (media fills)
  • Education: BS Engineering or Science
  • Experience - Required:  8+years Process Validation experience in Pharmaceutical, Medical Device or Parenterals.  Must have experience in either an FDA or ISO Regulated Industry
  • Experience - Desired:  Demonstrated experience and proficiency with cGXP, ICH and PIC/S.  Experience with regulatory and/or third party audits
  • Special Skills: Strong Verbal and Written Communication; Self Driven, TEAM WORK, Result Oriented, Strong knowledge of Process Validation, Project Management, Multi-tasking, Intermediate Statistics Knowledge  (sampling plans, hypothesis testing, etc), use of PFEMA risk assessment or similar, and solution aseptic filling experience

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

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