Job Description

Process Development Technician
Job Number: 21-01641
 
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Process Development Technician for our client in Andover, MA

 
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:
  • Seeking a highly motivated candidate to lead a continuous improvement project regarding the final fill step in a commercial biologic drug substance manufacturing process. Some legacy products currently employ a manual open-bottle fill step performed in a curtained HEPA area. Modern processes utilize a closed system. The goal of this improvement project is to modernize the legacy processes to incorporate a closed system for the final fill step.
  • As the legacy final fill processes are open and manual, they carry some risk of microbial contamination. The driver for this project is to minimize microbial contamination risk. The success of uninterrupted quality product supply relies, in part, on the continuous microbial control of the manufacturing process and the production environment.
  • Multiple sources of information and data, inclusive of and industry, will be integrated to identify the best process improvement option. Activities within the project team will require a high level of independence and the project lead will routinely make decisions to solve moderately complex problems.
  • As changes to the drug substance final fill process will also affect the drug product manufacturing process, the project lead must be comfortable working with colleagues at different client sites.
Responsibilities:
  • Collaborate with functional area representatives to drive continuous improvement initiatives
  • Apply technical and functional knowledge to design, develop and plan projects
  • Independently complete work within own work group/ project team
  • Must be able to interpret industry guidance and regulations for their applicability to any proposed improvements
  • Make decisions that require developing options to solve moderately complex problems
  • Use a variety of communication tools and techniques to explain difficult concepts and persuade others to adopt a point of view
  • Maintain a regular connection to client and industry
Qualifications:
  • Minimum of bachelors degree in project management, biologics manufacturing, engineering, microbiology, or related discipline
  • 7-10 years relevant experience within GMP biotechnology manufacturing environment
  • Knowledge of GMP compliance requirements
  • Successful track record of continuous improvement
  • Excellent oral and written communications skills, including presentation skills for various audiences required. Ability to influence stakeholders is essential
  • Expertise in project management, engineering, and/or microbiology are highly desirable and may be a differentiator between candidates
 
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:
Maria Castañeda
maria.castaneda@eclaro.com
6463571235
Maria Castañeda | 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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