Job Number: 25633056
Pay Rate: 64.51-66.9 USD/Hour
The pay ranges between $64.51 - $66.90 per hour.
- Bachelor's Degree in life sciences/engineering or equivalent.
- 0-3 years of relevant experience (prefer 2-3 years of experience), experience in the cell therapy industry and/or tech transfer/LCM preferred.
- Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
- Able to manage time and elevate relevant issues to the manager and appropriate project lead(s).
- Detail oriented with excellent verbal and written communication skills.
- Strong interpersonal skills to work with teams in different functions and organizations.
- The Process Engineer is responsible for supporting the implementation of cell therapy manufacturing technologies, and process changes related to the technical transfer of a clinical CAR T Therapy at the Cell Therapy Manufacturing Plant (Jump) in Bothell, WA.
- This includes supporting the Sr. Manager in establishing the requirements for the manufacturing process, coordinating technical transfers to manufacturing and between sites, developing process qualification and process documentation (Batch Records, Forms, etc.), E-Systems deployment, process control and comparability strategies, and contributing to the overall CMC and technical transfer/commercial strategy.
- Work will heavily involve the use and management of quality records, stakeholder relationships with Quality Assurance, global MSAT, Manufacturing, Supply Chain and Project Management organizations.
- Quickly and thoroughly learns the Client's cell therapy processes and tools defined by the team.
- Support the manager in Tech Transfer activities including prepping materials and providing progress reports to stakeholders at cross-functional team meetings, providing technical support for Process Design, validation, qualification, and comparability strategies, drafting, and reviewing technical documents.
- Impact assessor of change controls for process and procedure changes.
- Supports the completion of quality records and other associated change management for technical transfer readiness (change controls, deviations, Corrective and Preventative Actions).
- Functions as a technology and process subject matter expert.
- Applies continuous improvement tools to identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
- Follows change management SOPs, standards, policies, and directives, delivering a consistent flow of ongoing support production.
- Represents MSAT and interfaces with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Project Management to ensure best practices in industry related to technology transfers.
- Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful.
- Ability to perform gowning activities and enter the manufacturing plant.
- Working conditions are normal office environments, the GMP controlled cleanroom in the context of approved gowning and cleaning procedures, and handling of equipment.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
- The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
- There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
- Employees holding this position will be required to perform any other job-related duties as requested by management.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jacqueline: jacqueline@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01830
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE