14.11.22

Senior Validation Engineer

Lead Candidate has the privilege of partnering with organisations who are growing something special, making a difference to society through improved patient therapies and care. One such partner, INCOG Biopharma Services, headquartered in the US, is on the verge of ambitious growth and is looking to expand their team.

INCOG’s culture and priorities are different by design: focused on building long-term value for customers, committed to a service-culture mindset, technical excellence, and a collaborative and team-centred approach to doing business.

As INCOG builds a world-class CDMO for parenteral injectable drugs, they have recently completed construction of their GMP facility, but the journey has only just begun, which provides the opportunity to leverage knowledge gained over multiple careers to “do it right” in all respects.

The Opportunity

INCOG BioPharma Services are looking to appoint a Validation Engineer to partner with internal customers to meet the needs of client projects, facility upgrades, capital expansion projects, and laboratory systems.

This is where you come in – If you are an experienced Validation Engineer who has an understanding and experience implementing validation requirements for a sterile injectables manufacturing facility, we want to hear from you!

Utilizing your extensive experience in qualification and validation, the role will mostly involve:

  • Performing Qualification activities on utilities, equipment and laboratory systems. This includes, but is not limited to, clean utilities, autoclave, washer, filler, laboratory instruments, etc.
  • Interacting with clients to provide validation support including but not limited to, customer product launches, new equipment qualifications.
  • Supporting and providing validation oversight for capital expansion projects/build outs
  • Assisting with authoring validation lifecycle documentation and as well as document template, validation strategies and policies
  • Reviewing facility changes and provide input on re-validation and re-qualification of equipment
  • Assessing risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables
  • Engage in a cross functional team and work closely with other supporting groups including Engineering & Operations to support and monitor validation and process improvement efforts
  • Conduct validation qualifications in accordance with all applicable protocols and identify associated protocol excursions.

You

An experienced Validation Engineer, you will be a key individual contributor within the INCOG BioPharma Validation Department. The Validation Engineer is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. Additionally you will have:

  • Bachelor’s degree or higher in STEM discipline
  • 2-4 years of experience in Validation or related discipline
  • 1+ year GMP experience required or other regulated industry
  • Physically capable of working onsite

Based on-site in Fishers, Indiana, this role can’t be offered fully remote.

This is a genuinely rare opportunity to be involved in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, clients, and patients. INCOG strives to be different, putting the team at the forefront of everything they do and every decision they make.

If you want to be part of something special from an early stage, please contact one of our Talent Champions today at apply@leadcandidate.com

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