Process Engineer jobs in Lawrence, MA

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.

Rate/Location:

• $23.00 per hour
• This is a fully onsite position in Andover, MA

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits, and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued, and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.