Process Mechanical Engineer - Fill Finish Equipment
Overview We are looking for Intermediate and Senior Mechanical Engineers with experience in Fill Finish equipment to join our expanding Mechanical Engineering team. Our strong portfolio of upcoming pharmaceutical projects requires experienced professionals to help us deliver projects to our tier 1 clients in 2024. As a Mechanical Engineer, you will work as part of the Process Mechanical Engineering Team, owning Filling Line equipment packages through the complete lifecycle from design development through to integration on site. You will have the opportunity to work alongside our in-house Fill Finish Subject Matter Experts (SME) and develop your engineering skills. This role also provides excellent long-term career development, including the opportunity to progress along the PM Group technical career development path with the potential join our in-house SME development program. Who are we? PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of 3,500+ people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors. Responsibilities As a Process Mechanical Engineer – Fill Finish Equipment within PM Group you will be responsible for: Collaboration with in house Fill Finish SME network to ensure design adherence to latest industry standards and best practice Ownership of Fill Finish equipment modules and packages through complete lifecycle Specification of Fill Finish equipment through design and procurement phases Generation of Data Sheets, Material Requisitions & Enquiry Packages for procurement of Fill Finish equipment Generation of Technical Bid Tab Evaluation of vendors in compliance with Client specifications Developing Technical Specifications in compliance with Client requirements URS development for Client may be required on some projects Ownership of each package through Kick-off meetings, Design Reviews, FAT’s etc. Project manage Suppliers ensure packages are designed, manufactured and tested as per project requirements Interfacing with clients, vendors, client project management and other disciplines ensuring the highest level of service is provided Technical review of Vendor design to ensure interface with facility design team and adherence to client requirements and specifications Mechanical optimization/site support Qualifications To be considered for this role, you will have: Minimum of 5 years working directly on Fill Finish equipment through design phase. This may be through time at an equipment supplier, design consultancy or in a manufacturing environment Degree in Mechanical Engineering (Engineers with a primary degree in Chemical/Process Engineering and relevant process experience may also be considered) Significant design experience in the Pharmaceutical and Biopharmaceutical sectors Self-starter with confidence in coordinating the efforts of others Good communication skills (ability to lead Technical reviews with Clients and Suppliers) Openness to travel to where equipment is being manufactured Suitable Candidates shall have knowledge of some or all of the following areas: Aspects related to equipment such as: Deep knowledge of various filling and closing equipment RABs & Isolators Lyophilisers Inspection equipment Packaging equipment Principles of facility layout such as: Area classifications associated with the required process steps Layout adjacencies Segregation approaches Aspects related to unit operations and technologies such as: Small and Large volume parenterals Formulation Freeze/Thawing Filling and closing Lyophilisation Sterilisation and sanitisation Filling path Inspection Single use technology Component preparation and support areas Integrity testing CIP/SIP Clean Utility generation and distribution systems Waste systems Aspects related to facility operations such as: Operating philosophies Lean/Sigma Concepts Machine Efficiency (OEE) Contamination control GMP Regulatory framework, particularly Annex 1 and FDA