Process Engineer - Pioneer Data Systems
Andover, MA 01810
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Manufacturing Technician to join their expanding team.
Job Title: Manufacturing Technician / Pharma Industry
Duration: 12 months contract, extendable up to 36 months
Location: Andover, MA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Process Engineer
Summary:
The engineer/scientist in manufacturing Support operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance.
Additional roles include using operational and technical knowledge to lead, oversee, and evaluate troubleshooting activities, tech transfer and start-up activities, investigations, analyze/interpret process data, and identify and implement complex process improvements.
Responsibilities:
Initiate and supports risk assessments, change management and implementation for changes to the manufacturing processes and associated systems
POC and regular interactions with the Engineering, Quality, Site Technical Services, and Operational Management departments
Support Projects and Automation documentation revisions
Responsible for problem diagnosis/root cause(s) determination (automation, mechanical, documentation, training, etc) and co-ordinate resolution activities
Support and contribute to manufacturing investigations and CAPA
Identifies potential process improvement projects. Leads and Supports implementation of process improvements projects and supports compliance-driven projects that require technical support
Contribute to the development and modifications of operational process and equipment documentation including SOP, Job aid and Master batch records
Support Capital projects, and implementation and manage own time to meet the agreed targets
Serve as technical support within your assigned group, collaborating with outside groups as needed
Serve as the operations point of contact for campaign start-up with roles in site and risk assessment, generation of cGMP documentation, area preparation, process execution and summary reporting
Coordinate area clearance and product changeover within manufacturing process
Help in process monitoring including real time review of process parameters and process data/trend analysis
Implement process enhancements and measures and assist with the implementation of new technologies
Conduct skills training and provide subject matter expertise for training materials
Drive continuous improvement in the work processes associated with support of commercial manufacturing and change management
Work with network counterparts such as Grange Castle and Sanford in support of any impact or process-related issues.
Qualifications:
BA/BS in chemical engineering, biology, biochemistry or related science or engineering field
Minimum of 4+ years relevant experience with an engineering degree OR Master's degree with a minimum of 3+ years of experience
Automation, MCS or Delta V experience
Experience with Mammalian cell culture or microbial fermentation, centrifugation, tangential flow filtration, column chromatography
Project Management experience
Continuous Improvement or Project Management Certifications preferred
Previous experience in a GMP manufacturing environment preferred
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs preferred
Technical writing skills, as well as skills in Microsoft Applications preferred
Good verbal communication and ability to coach and provide guidance to others
Computer literate, with skills in Microsoft Applications and process tracking software
Able to work individually and in a team environment.
Location:
This is a fully onsite position in Andover, MA
Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Manufacturing Technician to join their expanding team.
Job Title: Manufacturing Technician / Pharma Industry
Duration: 12 months contract, extendable up to 36 months
Location: Andover, MA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Process Engineer
Summary:
The engineer/scientist in manufacturing Support operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance.
Additional roles include using operational and technical knowledge to lead, oversee, and evaluate troubleshooting activities, tech transfer and start-up activities, investigations, analyze/interpret process data, and identify and implement complex process improvements.
Responsibilities:
Initiate and supports risk assessments, change management and implementation for changes to the manufacturing processes and associated systems
POC and regular interactions with the Engineering, Quality, Site Technical Services, and Operational Management departments
Support Projects and Automation documentation revisions
Responsible for problem diagnosis/root cause(s) determination (automation, mechanical, documentation, training, etc) and co-ordinate resolution activities
Support and contribute to manufacturing investigations and CAPA
Identifies potential process improvement projects. Leads and Supports implementation of process improvements projects and supports compliance-driven projects that require technical support
Contribute to the development and modifications of operational process and equipment documentation including SOP, Job aid and Master batch records
Support Capital projects, and implementation and manage own time to meet the agreed targets
Serve as technical support within your assigned group, collaborating with outside groups as needed
Serve as the operations point of contact for campaign start-up with roles in site and risk assessment, generation of cGMP documentation, area preparation, process execution and summary reporting
Coordinate area clearance and product changeover within manufacturing process
Help in process monitoring including real time review of process parameters and process data/trend analysis
Implement process enhancements and measures and assist with the implementation of new technologies
Conduct skills training and provide subject matter expertise for training materials
Drive continuous improvement in the work processes associated with support of commercial manufacturing and change management
Work with network counterparts such as Grange Castle and Sanford in support of any impact or process-related issues.
Qualifications:
BA/BS in chemical engineering, biology, biochemistry or related science or engineering field
Minimum of 4+ years relevant experience with an engineering degree OR Master's degree with a minimum of 3+ years of experience
Automation, MCS or Delta V experience
Experience with Mammalian cell culture or microbial fermentation, centrifugation, tangential flow filtration, column chromatography
Project Management experience
Continuous Improvement or Project Management Certifications preferred
Previous experience in a GMP manufacturing environment preferred
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs preferred
Technical writing skills, as well as skills in Microsoft Applications preferred
Good verbal communication and ability to coach and provide guidance to others
Computer literate, with skills in Microsoft Applications and process tracking software
Able to work individually and in a team environment.
Location:
This is a fully onsite position in Andover, MA
Source : Pioneer Data Systems