Job Details

ID #43698335
State South Carolina
City Charleston
Full-time
Salary USD TBD TBD
Source Charles River Laboratories
Showed 2022-06-29
Date 2022-03-02
Deadline 2022-05-01
Category Science/biotech
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Ops Validation Engineer

South Carolina, Charleston, 29492 Charleston USA

Vacancy expired!

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

We are seeking a Ops Validation Engineer for our Microbial Solutions site located in Charleston, SC.

Develop and execute validation plans for equipment, and materials. Perform routine and non-routine maintenance on equipment associated with validation. Perform diagnostic review of equipment to ensure that the equipment is operating as designed and within validated parameters. Communicate with equipment vendors to trouble shoot any operational issues. Assist in the training of departmental production employees on technical operational skills and SOPs.

The following are the job duties & responsibilities related to the Ops Validation Engineer:

  • Assist in the validation of alternative materials
  • Perform reviews of validated materials and vendors
  • Review SCAR data to ensure compliance with internal standards
  • Assess suppliers capabilities, quality, and performance
  • Work closely with department personnel and vendors to select appropriate equipment for purchase when replacement or new equipment is required.
  • Work with vendors to become the subject matter expert (SME) for new equipment.
  • Author new SOPs and / or modify existing SOPs, Training Modules and BRFs as necessary to comply with validated parameters.
  • Assist in the implementation of new and / or changed SOPs, Training Modules, and BRFs.
  • Understand Quality Risk Management tools and terminology
  • Perform investigations related to validation
  • Author, execute and prepare validation protocols and final reports associated with equipment and instrumentation.
  • Author, execute and prepare validation protocols and final reports for computer systems associated with equipment.
  • Order supplies as needed for equipment validation. Serve as a knowledgeable resource for any production team member who needs assistance with equipment.
  • Coordinate the implementation of service improvements to equipment to prevent future malfunctions.
  • Ensure all processes and equipment are validated in line with regulatory requirements.
  • Participate in planning/coordination of projects for departments as needed.
  • Provide training on new equipment.
  • May act as team leader for departmental projects.
  • Work with a crossfunctional team to complete various validation activities.
  • Responsible for documentation as required by the company policy, cGMP and FDA.
  • Perform general housekeeping and adhere to safety procedures.
  • Perform all other related duties as assigned.

Job Qualifications

The following are the minimum qualifications related to the Ops Validation Engineer:

  • Education: Bachelor’s Degree in Science, Electronics, or related discipline.
Experience: Minimum of one year related experience and/or training.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure: None.

Other: Advanced computer and math literacy required. Experience in regulated industry (pharmaceutical or bio tech) strongly preferred. Effective communication and interpersonal skills required

About Microbial Solutions Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

Vacancy expired!

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