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Pioneer Data Systems



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Process Engineer


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Job ID:

247406

Search by Country Location:

Andover, MA, United States 
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Job Views:

18

Posted:

07.05.2024
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Job Description:

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