Engineering Technical Lead
Company: International Biopharmaceutical
Location: Amsterdam Area
Starting date: 1 March
Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. We are currently seeking a Engineering Technical Lead to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
This role will be directly responsible for facilitating the project technical requirements for a Phase B Expansion project. Also, The Engineering Technician lead will manage the design evolution process to execute and effectively turn over the project to Operations at project completion. The project duration extends through Q2 2023. The candidate should have experience in design and construction of GMP “clean room” manufacturing facilities. In addition, experience with Manufacturing Equipment Systems (MES) and Electronic Batch Record (EBR) implementation is a plus.
The ETL will monitor the technical/design deliverables for quality and scope. Additionally, the ETL will ensure that the design development process has the appropriate input from all stakeholders, users and Subject Matter Experts (SME's) to progress appropriately through the design process in a manner that is timely, efficient, thorough and effective.
Design - Programming/BOD/Conceptual/Basic/Detailed Design
• Ensure that the quality and completeness of the design deliverables is defined and met.
• Primary point of contact with the A/E design firm and with the internal stakeholders for technical/design issues.
• Ensure the programming through design completion effort is defined with clear goals/milestones.
• Ensure User/SME participation in the appropriate development work sessions.
• Utilizing SME's, monitor progress for proper technical content.
• Provide technical information to the project as needed either via Guides/Standards and/or technical assessments to ensure the design follow organizational standards and guides and meet the project goals/deliverables.
• Responsible for the execution of risk management mechanisms (Quality, Safety, Business Continuity) via the appropriate risk measurement tool (FMEA, HAZOP, PHA).
• Ensure technical/engineering deliverables are defined and developed commensurate with the design stages.
• Provide technical review of documentation including Engineering SOPs, Engineering drawings, functional test plans, User Requirements Specifications (URS), FATs and SATs
• Support constructability reviews with the design team and Construction Manager.
• Ensure the BIM (Building Information Modeling) process is clearly defined and contracted (working with Drawing and Document Management team)
• Responsible for the initiation and execution of the Engineering Change Management (ECM) process, including approval of Engineering Change Notices (ECNs.).
• Ensure the proper review and response of Submittals and RFI's are executed by the A/E of record effectively and in accordance with the contract.
• Ensure identified scope gaps and scope additions are technically assessed in accordance with the ECM process.
• Utilizing SME's, support the periodic review of field installations ensuring field work is performed in accordance with the contract documentation and specifications.
• Ensure the General and Sub-contractors have coordinated all field routing and meet the design and specifications for accessibility.
• Ensure a clear system-by-system definition of Mechanical Completion and systems are started up in accordance with design, vendor requirements and can be operated safely.
• Ensure the Transfer of Care and Custody (ToCC) of each system is defined and executed.
• Ensure the contractor field redlines are maintained through the construction duration.
Commissioning (responsibilities will be shared with F&E Validation lead, but ETL retains accountability)
• Responsible for the development, approval and execution of the Commissioning Plan (CP) for the project.
• Ensure the Commissioning plan is coordinated with the project Validation Project Plan (VPP).
• Responsible for the execution of the project CP.
• Ensure SME's review and support the development and execution of the CP.
• Responsible for the final documentation and closure of commissioning prior to project closeout.
• Responsible for the review and approval of the final construction Turn-Over Packages (TOPs).
• Responsible for the review and approval of the final design documentation Turn-Over Packages (TOPs).
• Ensure there is technical/SME support for the transfer from Construction to Operational Readiness.
• Provide regulatory documentation as needed such as; area classification and pressurization diagrams, P&ID's, personnel and material flow diagrams.