- Expiry Date: 16 September 2021
we are looking for Manufacturing Operations Engineer I / II to join our team in Global MSAT. The successful candidate will be based in US with combination of on-site and remote work supporting our CMO and collaborate with the US-based GMSAT team to lead efforts related to technology transfer and continuous commercial manufacturing of our cell therapy products. This engineer will have responsibilities like an internal MSAT organization for CTDO’s cell therapy manufacturing CMO site(s) with the focus on supplementing the technical capabilities of the CMO. This person will be responsible for supporting on site/off site execution of MSAT tasks including clinical and commercial manufacturing support.
The Manufacturing operations engineer will also support technology transfer to CMOs including creation, changes, and enhancements to process documentation (batch records, work instructions, SOPs, etc.) occurring at CMOs. The person will be responsible for process monitoring activities, which include real time tech support for batches (Person-in-Plant) and will ensure all unit operations are carried out per approved production batch record instructions. Additionally, the engineer will be responsible to support execution of any MSAT activities along with support for Continued Process Verification (CPV). This engineer will work closely with a cross-functional team of members from QA and external manufacturing to support all MSAT related activities at external CMOs.
Responsibilities Include, But Are Not Limited To, The Following:
Provide on-site technical process support for on-going manufacturing, routine clinical and/or commercial cell therapy products at the CMO.
Review and approve manufacturing batch records, change controls, and deviations authored by the CMO.
Review executed batch records to ensure process is operating within the validated state
Work with technical and quality teams at CMO to evaluate and implement process improvements
Author risk assessments, study protocols, and technical reports and revise process documents as needed to support technology transfer and process changes
Perform and support data monitoring of manufacturing processes to understand process capability, resolve production issues and troubleshoot investigation-driven events
Ensure the manufacturing process is in a state of control, through an understanding of CPV data.
Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
Leverage and maintain strong relationships with external CMOs and their vendors.
Support permanent inspection readiness and actively support regulatory inspections.
Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product.
Share operational best practices and process learning with the rest of the manufacturing network.
Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.
Excellent documentation skills with attention to detail.
Experience with cGMP, ICH guidelines, PPQ (process validation), and working within a Quality organization.
Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
Excellent problem-solving skills.
Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
Able to creatively manage time and elevate relevant issues to project lead and line management.
Detail oriented with excellent verbal and written communication skills.
MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 1-3 years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
Experience with cell culture or aseptic techniques is preferred.
Experience in a regulated, GMP manufacturing environment is required.
Flexibility to work within manufacturing schedules. Combination of on-site and remote work available.
Excellent communication, writing, sense of urgency, teamwork, and presentation skills.
Strong interpersonal skills required to work with teams in different functions and organizations.
Operational excellence training/background is preferred.
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