CEL - PROCESS ENGINEER
Job Number: 21-01583
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Process Engineer for our client in Devens, 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!
- The process engineer, technical writer, authors Standard Operating Procedures (SOP), technical protocols and technical reports to support manufacture of CAR-T therapies in accordance with Current Good Manufacturing Practices (cGMPs).
- This role requires effective collaboration across technical functions to deliver on timelines for submissions.
- Responsibilities include authoring standard operating procedures, authoring technical protocols and reports and managing the flow of documents through an electronic document management system.
- Expertise manipulating templates, tables and graphics.
- Ability to manage simultaneous creation of multiple technical documents. Delivery of documents by due dates.
- Strong knowledge of commercial GMP manufacturing operations is essential. Knowledge of cell therapy manufacturing operations is preferred.
- Ability to work independently and handle multiple priorities in a dynamic cross-functional team based environment.
- Utilization of good communication skills to effectively collaborate with co-workers at all levels of the organization.
- Works on routine manufacturing assignments as well as assignments that are complex in nature where action and a high degree of initiative are required to resolve problems and make recommendations.
- Strong aptitude with Microsoft office suite with ability to interpret and understand the technical source document.
- Knowledge of science generally obtained through Associates or 4-Year degree in engineering, biochemistry or related discipline is preferred.
- A minimum of 5+ years’ process operations experience in a biotechnology or cell therapy manufacturing facility subject to GMP regulations with at least one year experience with technical writing.
- Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).
- Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
- Previous work experience where attention to detail and personal accountability were critical to success
- Demonstrates good interpersonal skills, is attentive and approachable.
- Maintains a professional and productive relationship with area management and co-workers.
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 | 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.