Engineering - Process Engineer Process Engineer
Job Number: 21-14316
Job Number: 21-14316
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Process Engineer for our client in Warren, 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!
- The position will be responsible for the routine MSAT support to our ex-US CMO partners.
- This engineer will have responsibilities like an internal MSAT organization for Client’s cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement.
- This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support.
- The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply.
- The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up work force training.
- Provide technical process support for routine clinical and/or commercial cell therapy manufacturing at the CMO.
- Support production related investigations, ensuring compliance with internal standards and regulatory requirements
- Identify and propose continuous process improvement projects to management.
- Support process and procedural changes to improve manufacturing performance, robustness, productivity, safety, and efficiency.
- Perform monitoring of manufacturing processes to understand process capability.
- Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
- Leverage and maintain strong relationships with external partners
- Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
- Maintain permanent inspection readiness and actively support regulatory inspections
- Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
- Share operational and process leaning with the rest of the manufacturing network.
- B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
- Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)
- Experience working within Quality Management systems including providing deviation, investigation, and CAPA support
- Experience with cellular therapies is strongly preferred
- Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
- Familiarity with literature on process development and cell therapy
- Excellent communication, writing, organizational, teamwork, and presentation skills
- Strong interpersonal and leadership skills to work with teams in different functions and organizations
- Onsite Position with flexibility of working remote
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:
Jane Bautista | 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.