Subject Matter Expert - Assembly Process Engineer
- Electrical Schematics
- PROJECT MANAGEMENT
- FOL-EOL ASSEMBLY PROCESS ENGINEERING
- ASME BPV
- ASME BPE
- Supporting and driving the project funding process and providing project and technical leadership for department capital projects, of medium to high complexity, in the 2 Sub and Final Assembly plants as a Production Assembly subject matter expert (SME).
- The candidate will provide SME input and advanced process equipment technical design support and overall project leadership duties.
- Develop and mature new processes and process equipment technologies from proof of concept through to GMP clinical/commercial manufacturing by applying the right degree of rigor for each phase of implementation, increasing GMP readiness along the way.
- Partner closely with the pre-pivotal and pivotal development groups to identify meaningful process requirements and ensure logical, systematic translation of design requirements and constraints into process equipment/system solutions.
- Support a safe working environment by complying with environmental health/safety best practices, and industry regulations.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Prepare and present project updates to technical teams and management.
- Lead implementation of key department goals and initiatives.
- Bachelor’s degree in Industrial or Mechanical Engineering
- Relevant work experience in an industrial or mechanical engineering role including 1+ years of experience in an operations/manufacturing environment.
- Ability to read and understand engineering drawings (e.g. P&IDs, PFDs, GAs, Electrical Schematics) and ability to draft and develop P&IDs and PFDs.
- Experienced with single-use process systems. Substantial capital project support and design experience.
- Basic understanding of industry regulations and experience with regulated environments (e.g. cGMP, OSHA, EPA, ASME BPV, ASME BPE etc.).
- Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.
- Leadership, technical writing, and communication/presentation skills.
- Experience with change control, process incidents/non-conformances, corrective and preventative actions, and commissioning and qualification practices.
- Experience in engineering directly related to door lock production including facility design, procurement, construction, startup, and qualification.
To apply for this job email your details to firstname.lastname@example.org.
23rd January 2020
31st March 2020