Description: Our client is currently seeking a Senior Engineer, Process Engineering for a 12 month + contract.
Need one engineer to have some experience with the equipment PLC programming and the other to have good experience with validation work.
Job Description
1) Who we want: This role is within the Product Transfer team. The role contributes to the delivery of high impact, cost transformative projects. The role will require the successful candidate to operate across a network of stakeholders from Product Transfer, Operations and Divisional partners, therefore strong interpersonal skills and communication skills will be necessary.
What you will do: Provide engineering support for product transfers ensuring that all activities are completed and documented in accordance with the latest procedures. Determine the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment. Monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures. Analyze equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings. Coach and mentor others on functionally related topics. Ensure quality of process and product as defined in the appropriate operation and material specifications. Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. Participate in PFMEA, Control Plan, SOP, PPAP and other Stryker internal process qualification generation associated with product transfers. Ensure adherence to GMP and safety procedures. Review and approve of validation documentation. All other duties as assigned.
Minimum Qualifications, (Required):
Bachelor's degree in an engineering discipline.
Minimum of 4 or more years' experience in a FDA regulated manufacturing or project environment.
Experience of process/ product validation.
Experience with statistical methods, process mapping, root cause analysis.
Experience coaching and mentoring team members, managing and coordinating projects, workstreams and activities.
Interpersonal Skills, express ideas and collaborate with multidisciplinary teams.
Open minded with the ability to recognize good ideas.
Innovative thinker, able to envisage new and better ways.
Experience in executing complex problem-solving techniques related to manufacturing technical issues.
Good instincts and sound judgement for mechanical and structural design.
Experience in executing complex problem solving techniques related to manufacturing/design technical issues.
Good instincts and sound judgement for mechanical and structural design.
