Process Validation Engineer-Pharmaceutical or Biotech Hickory,  NC

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Process Validation Engineer-Pharmaceutical or Biotech

Job Title
Process Validation Engineer-Pharmaceutical or Biotech
Job ID
Hickory,  NC 28602
Other Location
Process Validation Engineer- Pharmaceutical or Biotech:  Exciting high profile Immunotherapy Company that manufacturers and markets products centered upon treating allergic disease through improved and innovative methods.  They are seeking an AssociateDegreed OR Bachelor Degreed Engineer responsible for the creation and execution of validation projects for equipment, facilities, and utilities in an aseptic manufacturing environment. This includes creating, executing, and approval for qualification protocols and reports. The position will create qualification activities and coordinate executions efforts with operations, facilities, laboratory, and material management.

Primary Responsibilities:
  • Independently plan, perform and/or coordinate validation projects to ensure timely completion.
  • Draft and coordinate execution of process validation and equipment qualifications (IQ, OQ, PQ).
  • Draft/or provide technical guidance for SOPs and other master documents.
  • Remain current with industry and regulatory agency trends.
  • Keep Validation Manager informed of the status of validation activities and projects.
  • Support Engineering and Operations in the development of critical process parameters.
  • Provide technical leadership for deviation investigations.
  • Analyze data and provide recommendations for improvements in manufacturing process, and equipment.
  • Prepare protocols and other technical documents, and participate in the interpretation of data, collaborating with other departments. 

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Position Location and Coverage
  • Lenoir or Hickory, NC area (73 miles North west of Charlotte, NC)
  • Some relocation assistance will be offered to this beautiful and affordable locale! 
  • Salary range: 65K to 75K 
  • Rich Benefits: Medical, Dental and etc.

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Required Skills
• Aseptic manufacturing understanding/experience is a must.
• 2-3 years of industry experience in pharmaceutical or biotech involved in equipment and/or process validation.
• Results-oriented, able to make independent decisions, and able to prioritize work per business needs in a fast paced environment.
• Good understanding of CGMP/GLP validation requirements and current industries practices.
• Strong written and verbal communication skills.
• Strong project management skills.
• Superb attention to detail and ability to meet deadlines.
• Strong understanding in the qualification of steam and dry heat sterilization, and Water for Injections systems.
• (AS Degree)Associates Degree in engineering discipline or science related field

Optional Skills
• 4 Year Engineering degree is not mandatory, but preference given to candidates who have it.
• 1-2 years of software validation experience is desired, but not required.
Pay Range
$65,000.00 Annually to $75,500.00 Annually

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