Job Description

Process Engineering & Validation Expert 1
Job Number: 20-06060
Be a part of a company that supports life-changing healthcare solutions. Eclaro is looking for a Process Engineering & Validation Expert 1 for our client in Bedford, MA. 
Eclaro’s client is a leading manufacturer of lab materials, technology and service supporting the Life Science field. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
  • The department the position will report to is Gene and Cell Therapy Engineering, specifically Product Engineering.
  • The Product Engineering function is multifaceted.
  • Its primary function is to deliver innovative and effective validation documentation and strategy for upcoming commercial products in the pipeline, while also serving as a bridge between R&D and Production.
  • The Validation Technician will also support the Wilbraham facility in development and remediation of critical upcoming projects and revs/modification on current ones.
  • Gene and Cell Therapy Bioprocess creates, designs and manufactures single use assemblies for autologous cell therapy manufacturing.
  • Every assembly we manufacture has been specially designed to meet a certain application for a specific customer.
  • As the industry grows, so does the expectations and requirements come from our customers.
  • This position will serve as a valuable resource, gathering data critical to supporting the product engineering team in their efforts to meet new product requirements.
  • Responsibilities for this role will include:
    • Supports analytical instrument qualification/validation and projects by executing validation protocols ensuring compliance with cGMPs as well as above site policies and procedures.
    • Familiar with ASTM and procedures regarding validation of consumables.
    • Reports findings and summarizes execution of analytical instrument qualification/validation protocols and support documents (amendments, repeat test forms, addenda and deviations).
    • Interface with R&D engineers, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
    • Provides input validation activities.
    • Participate in the quarterly Analytical Instrument Working Group meeting.
    • Participates in site projects and initiatives as necessary.
Required Skills:
  • Strong computer skills and learning agility; capable of using and learning software tools used to manage projects or run equipment
  • Strong communication skills; written and verbal
  • Goal oriented and works well with limited supervision.
  • Strong ability to quickly absorb product knowledge is key.
  • Detail oriented, self-motivated, and organized.
  • Technical skills: Proficient with Microsoft Office, Formal report writing, PowerPoint presentations, Experience with SolidWorks is a plus
  • Technical degree with 2-5 years of industry-related experience (Validation, QA, QC, manufacturing)
  • Minimum of 1 and 1-5 years of hands-on validation experience.
  • Solid organization, problem-solving, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
  • Experience with SOPs, Report writing, Protocol execution, Protocol writing, Process development
  • Familiar with the validation of analytical instruments used within biopharmaceutical manufacturing.
  • Understanding of the requirements of a Biopharma/regulated environment.
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:
Paul Quibuyen
Paul Quibuyen | 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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