Technical Project Lead Mechanics / Pharma (5327)
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For our client, a leading Swiss CMO and Pharma company, we are looking to fill a contract assignment as a
Technical Project Lead Mechanics / Pharma (5327)
Located in the Valais in Switzerland and associated to the company's Strategic Growth Investments & Engineering Unit, this role is initially limited to 12 months, with a possible extension to Q1 2025.
The main objective of the role is to assure a proper application of the 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.
Responsibilities
• Enforce the use and application of company standards
• Study & understand the scope of the project and the applicable standards
• Build network in local organization with all important stakeholders
• Proactively align and keep aligned with the company Project Team (Process, Plant Engineer, OPS Team, SGU, QA, QC, 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 occurs.
Candidate profile:
• 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
• Must be able to quickly adapt to changed conditions
• Needs to know the world of the company Standards and GMP
• Capable to convey the company requirements to the whole project team
• Establish network locally to stay aligned with local Engineering
• Assure that the standards are applied right the first time
• Sufficient self-esteem (but no arrogance) to convince senior SMEs about the need to apply the technical standards
• Fluency in English is a must, Fluency in German advantageous