The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
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.
• 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.
• 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