Job Description

Process Engineer
Job Number: 20-06059
 
Be a part of a company that supports life-changing healthcare solutions. Eclaro is looking for an Process Engineer 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:
  • To support Product Engineering Validation projects.
  • Will report specifically to 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.
  • Will also support the facility in development and remediation of critical upcoming projects and revs/modification on current ones.
 
Responsibilities:
  • 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 writing and executing validation protocols ensuring compliance with cGMPs as well as above site policies and procedures.
    • Familiar with ASTM and Industry Standards and procedures regarding validation of consumables.
    • Authors final reports summarizing execution of analytical instrument qualification/validation protocols and support documents (amendments, repeat test forms, addenda and deviations).
    • Responsible for continuous improvement of analytical instrument validation program and assuring compliance with MS policies and procedures.
    • Interface with R&D, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
    • Interface with regulatory authorities and partners as the SME for the analytical instrument validation program.
    • Schedule and coordinate validation activities with vendors, system owners and key stakeholders.
    • Participate in change control reviews.
    • Responsible for participating in the quarterly Analytical Instrument Working Group meeting.
    • Participates in site projects and initiatives as necessary.
    • Read and Create CAD models in SolidWorks
 
Required Qualifications:
  • BS/BA in a in Engineering with 3-5 years of industry-related experience (Validation, QA, QC, manufacturing) (MS is a plus)
  • Minimum of 1 and 1-5 years of hands-on validation experience.
  • Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
  • Experience with SOPs, eDocCompliance, 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.
  • Knowledge of 21 CFR 11 requirements.
  • Skills & Ability:
    • 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
 
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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