Job Description

Process Engineer
Job Number: 20-10610
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Process Engineer for our client in New Brunswick, NJ.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • A Process Engineer for the Parenteral External Manufacturing group.
  • Will provide systems, documentation and technical support for manufacturing of Client biologic drug products at Contract Manufacturing Organizations in the US.
  • This position will report into the Associate Director.
 

Responsibilities:
  • Provide first line systems and documentation support to manage QE and Change Controls at CMOs in Trackwise, Infinity and other Quality and document systems
  • Provide technical support to contract manufacturing organizations to enable technology transfers and commercial manufacturing. This includes review and approval of site documents such as characterization Protocols, Validation Protocols, Process Risk assessments, etc.
  • Support of critical manufacturing or complaint investigations including, root cause analysis, CAPA generation, and impact assessment
  • Qualifications, Knowledge and Skills Required:
 

Qualifications:
  • Hands-on experience with quality systems, documentation systems and ability to process change controls, deviations and CAPAs. Good knowledge of Sterile or Biologics manufacturing technology, and experience in working with CMOs with a minimum of 5 years of experience is required.
  • A bachelor’s degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) or requisite equivalent experience is required.
  • Experience / Knowledge Desired:
    • Experience of working with trackwise and or infinity system to provide documentation support for change control and investigation
    • Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
    • Strong technical writing skills.
    • Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
    • Ability to work within cross-functional technical teams, across multiple cultures.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Jay Lucas   
arjay.lucas@eclaro.com
6463571240
Jay Lucas | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. 

Application Instructions

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