Senior Associate Engineer
Title:
Senior Associate Engineer Location:
Devens, MAStart date:
ASAPOur client is looking for the following:
Responsibilities:
oResponsible for supporting commercial manufacturing performance at the external manufacturing site.
Represents MS&T external manufacturing team to provide person in plant technical support to the commercial manufacturing process including deviation resolution, change management, delivery of yield targets and optimization.
oMaintains strong working relationships with external partner(s).
oInterface with internal functions such as MS&T, Quality, supplier Change Manager and Supply Chain.
oDevelop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving.
oTracks progress of routine manufacturing and tech transfer projects against schedule, provides routine updates and proactively identifies operational risks and remediation.
oEnsures timely escalation of potential technical, compliance or safety issues to the SRM/MS&T team and partners with internal MS&T resources to remediate.
oEnsures effective communication between technical and quality representatives at the contract manufacturing sire, including other PIP team members.
oLead/support technology transfer activities as applicable.
oImplement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements.
oExpectation to travel to Syracuse once a month20 to 30% of time would be required to travel to this siteWith the following credentials:
Requirements:
oEducation:
Bachelor's Degree RequiredMaster's Degree is DesiredoScience or engineering degree in biotechnology, biochemical or related discipline.
oExperience in drug substance manufacturing essential to the role.
oA strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
oDemonstrated ability to work independently and prioritize activitiesoA proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essentialoExperience in technology transfer of processes for commercial manufacture and associated regulatory requirementsoAbility to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisionsoDemonstrated ability in technical writing, computer-based knowledge, and communication skillsSystem One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
Recommended Skills Biochemistry Biotechnology Business Process Improvement Cell Cultures Change Management Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Senior Associate Engineer Location:
Devens, MAStart date:
ASAPOur client is looking for the following:
Responsibilities:
oResponsible for supporting commercial manufacturing performance at the external manufacturing site.
Represents MS&T external manufacturing team to provide person in plant technical support to the commercial manufacturing process including deviation resolution, change management, delivery of yield targets and optimization.
oMaintains strong working relationships with external partner(s).
oInterface with internal functions such as MS&T, Quality, supplier Change Manager and Supply Chain.
oDevelop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving.
oTracks progress of routine manufacturing and tech transfer projects against schedule, provides routine updates and proactively identifies operational risks and remediation.
oEnsures timely escalation of potential technical, compliance or safety issues to the SRM/MS&T team and partners with internal MS&T resources to remediate.
oEnsures effective communication between technical and quality representatives at the contract manufacturing sire, including other PIP team members.
oLead/support technology transfer activities as applicable.
oImplement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements.
oExpectation to travel to Syracuse once a month20 to 30% of time would be required to travel to this siteWith the following credentials:
Requirements:
oEducation:
Bachelor's Degree RequiredMaster's Degree is DesiredoScience or engineering degree in biotechnology, biochemical or related discipline.
oExperience in drug substance manufacturing essential to the role.
oA strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
oDemonstrated ability to work independently and prioritize activitiesoA proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essentialoExperience in technology transfer of processes for commercial manufacture and associated regulatory requirementsoAbility to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisionsoDemonstrated ability in technical writing, computer-based knowledge, and communication skillsSystem One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
Recommended Skills Biochemistry Biotechnology Business Process Improvement Cell Cultures Change Management Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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