Lead System Designer III

Hello,
Hope you are doing well.
 
I came across your resume on Job board and am reaching out to you because I feel you might be a great match for a “Lead System Designer III”  opening that I am looking to fill for my client in “Westborough, MA, 01581”. “This position is with a  high growth company”  the project duration is for approximately 6+ months Contract to Hire. I would appreciate a few moments of your time to go over the job description and see if this position might be a mutual fit
 
Description:
This is a potential temp to perm position for the right candidate. Please ask your candidate(s) if they are legally authorized to work for any employer in the US without sponsorship and ensure the question is answered/confirmed in the comments when you submit the candidate(s). Thank you! 
 
Coordinate the detailed design and solve any design issues during the design phase and acts as a contract for system design related questions. Participates in developing and updating the FlexFactory project schedule. 
 
Duties include: 
Support customer meetings by providing system hardware understanding. Develop, explore and recommend manufacturing concepts to fit customer needs/facility requirements. • Assure compliance with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position • Work closely with Customer’s Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time • Complete all planned Quality & Compliance training within defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Work closely with Process Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility. • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones • Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives • Approximately 10-30% travel depending on project specifics and geographic location 
 
Qualifications/Requirements 
• BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline 
• Minimum of 5 years of relevant bioprocess experience 
• Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology 
• Thorough knowledge of biologics CMC, cGMP manufacturing requirements 
• Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.) 
• Experience in working/leading within cross functional teams 
• Experience with AutoCAD, Visio, MS Project, SuperPro 
• Fluent in English both verbally and in writing 
 
Desired Characteristics 
• Master’s Degree 
• Disposable technology design and application experience 
• 2 years of direct experience working in a pilot plant or GMP manufacturing facility 
• Detail oriented, excellent at critical analysis and problem solving 
• Experience working in global business environment with sound understanding of global processes 
• Open to a changing environment 
• Structured, organized, Analytical, Team oriented
 
Regards
 
Ronny Dsouza
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560
ronny@apninc.com
Phone: 510-870-8707

Want to apply later?

Type your email address below to receive a reminder

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file