Overview
On Site
USD 55.00 - 70.00 per hour
Full Time
Skills
Marketing Intelligence
MI
Process Engineering
Network
Communication
Engineering Support
Policies and Procedures
NPI
Design Of Experiments
OQ
PQ
Testing
Inspection
FMEA
SOP
PPAP
GMP
Documentation
Process Mapping
Root Cause Analysis
Coaching
Mentorship
Management
Collaboration
Problem Solving
Conflict Resolution
Manufacturing
Mechanical Engineering
Structural Engineering
Continuous Improvement
Process Improvement
Six Sigma
SCADA
Privacy
Marketing
Job Details
Location: Kalamazoo, MI
Salary: $55.00 USD Hourly - $70.00 USD Hourly
Description: Our client is currently seeking a Senior Engineer, Process Engineering for a 12 month + contract.
Looking for an engineer with validation experience.
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. Owns and supports the development of the Validation Plan for highly complex validation projects. Owns and supports validation and initial qualification of equipment and systems as related to new equipment for NPI/Product Transfer activities. Write, review, and execute studies for process validation, including DOE, OQ, and PQ 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 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, Knowledge, Skills (Required):
Bachelor's degree in an engineering discipline. Minimum of 2 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. Proven track record of working in a team based environment. Experience coaching and mentoring team members. Experience in managing and coordinating projects, workstreams and activities. Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognize good ideas. Innovative thinker - should be able to envisage new and better ways of doing things. Experience in executing complex problem solving techniques related to manufacturing/design 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. Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing. Preferred
Qualifications (Desired): Continuous Improvement and Project / Process Improvement related experience. Green or Black Belt 6 Sigma qualifications. Experience with SCADA systems
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $55.00 USD Hourly - $70.00 USD Hourly
Description: Our client is currently seeking a Senior Engineer, Process Engineering for a 12 month + contract.
Looking for an engineer with validation experience.
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. Owns and supports the development of the Validation Plan for highly complex validation projects. Owns and supports validation and initial qualification of equipment and systems as related to new equipment for NPI/Product Transfer activities. Write, review, and execute studies for process validation, including DOE, OQ, and PQ 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 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, Knowledge, Skills (Required):
Bachelor's degree in an engineering discipline. Minimum of 2 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. Proven track record of working in a team based environment. Experience coaching and mentoring team members. Experience in managing and coordinating projects, workstreams and activities. Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognize good ideas. Innovative thinker - should be able to envisage new and better ways of doing things. Experience in executing complex problem solving techniques related to manufacturing/design 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. Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing. Preferred
Qualifications (Desired): Continuous Improvement and Project / Process Improvement related experience. Green or Black Belt 6 Sigma qualifications. Experience with SCADA systems
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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