Sterile Pharmaceutical Equipment Specialist

7 days ago


Brighton, Michigan, United States Bryllan LLC Full time

Job Description

Bryllan LLC, a contract manufacturing organization (CMO) in Brighton, Michigan, specializes in sterile injectable pharmaceuticals. We are seeking a skilled Sterile Pharmaceutical Equipment Specialist to join our team.

About the Role:

The successful candidate will be responsible for overseeing the design, procurement, and qualification of equipment used to manufacture pharmaceutical products. This role requires strong focus on driving quality into production processes, implementing best practices, and continuous improvement.

Responsibilities:

  1. Work closely with the Process Development Team to ensure all equipment meets technical requirements for intended processes.
  2. Develop technical documentation required for the qualification of pharmaceutical process equipment.
  3. Coordinate with vendors throughout design and procurement phases to ensure equipment is correct for intended purpose and delivered on time to meet manufacturing schedule.
  4. Provide routine technical support and troubleshooting for resolution of equipment issues.
  5. Provide technical training on equipment as required by Operations.
  6. Act as assigned technical lead and owner of manufacturing process equipment.
  7. Participate in project teams for various new equipment needed in support of manufacturing activities.
  8. Provide engineering solutions and designs for new equipment to be used in the manufacturing of sterile drug product.
  9. Ensure work activities are conducted in strict accordance with safety guidelines and processing standards cGMP's and SOP's.

Requirements:

  • Minimum four-year Degree in Engineering or Engineering Technologies.
  • Strong mathematical and organizational skills.
  • Excellent interpersonal skills with ability to communicate effectively.
  • Basic computer skills (proficient in Microsoft Office applications).
  • Knowledge of cGMP and regulatory principles.

Compensation:

$75,000 - $90,000 per year, depending on experience.

We Offer:

  • A dynamic work environment.
  • Ongoing training and development opportunities.
  • A competitive salary and benefits package.


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