Pharmaceutical & Biotechnology
Technical Project Lead
PE Global is currently recruiting for a Technical Project Lead Mechanics for a leading multi-national pharma client based in Switzerland.
This is an initial 12-month contract position.
The main objective of the Job is to assure a proper application of our clients Technical Standards right the first time. To achieve this, the TPL Mechanics is in close collaboration with the technical team during the design phase, FATs / SATs and commissioning until IQ / OQ. Sharing technical standards and auditing their compliance is key. Solid technical knowledge is mandatory to understand the content, enabling e.g. the review of P&IDs.
- Enforce the use and application of our clients standards
- Study & understand the scope of the project and the applicable standards
- Build network with all important stakeholders
- Proactively align and keep aligned with the Project Team (Process, Plant Engineer, OPS Team, SGU, QA, QC, Visp Engineering, EPCMQ team) about the applicable technical standards
- Share the technical standards with the project team. Save them or their links on the project SharePoint
- Make the Work Package Owners (= SMEs of the EPCMQ or suppliers) aware about the
standards corresponding to the specific equipment
- Participate in the technical meetings between the Work Package Owners and the suppliers
- Review and approve P&IDs
- Coordinate the declaration of conformity according to PED
- Participate in the corresponding approval workflows in Unifier and CQV
- Participate in FATs / SATs as observing auditor
- Technical Change Management: Lead discussions if a proposed change is mandatory
or a “nice to have”. Coordinate TCRs in SAP.
- Prepare the handover of technical information from the EPCMQ to Plant Engineering and execute it when the initial handover
- Ensure the compliance with all pertinent safety policies, rules and
- Establish the project CAPEX charter including scope of work, goals and deliverables together with the relevant site level senior management and
- Execute the CAPEX project according to budget, scope and on-time deliverables
- Ensure that the adequate project control systems needed to manage the risk, cost and schedule are timely in place.
- Conduct regular engineering and project control reviews with the project team in order to ensure that the project execution is on track (safety, quality, cost & schedule) and to identify and implement remedial action(s) in case of any deviation from project
- Define and implement overall project resources (internal and external) and to provide daily leadership
- Ensure the implementation of the state-of-the-art technical solutions and to ensure compliance with internal and external quality, safety and ecology
- Ensure the sharing and leveraging of best practices and expertise within our clients
- Ensure the successful hand-over the project to the user-team including the right level of training and correct
- Bachelor or Master degree in Engineering (process, pharmaceutical, biochemical or equivalent)
- Experience with microbial process equipment and Delta V software
- Strong understanding of design in all project phases and process operations in microbial upstream, downstream and/or conjugation
- Collaborative personality, strong decision maker, and ability to work independently
- Will interface: Process and Manufacturing Leads, Plant Engineering and other support functions, EPCM partners
- Fluency in English is a must, Fluency in German advantageous
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to email@example.com