Senior Process Engineer

Duration: 12 Months

Pay Rate: $30/hr on w2 without benefits

BA/BS in chemical engineering, biology, biochemistry or related science or engineering field. Minimum of 4+ years relevant experience with an engineering degree or, MS +3 yrs.

• 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.

Automation, MCS or Delta V

Mammalian cell culture or microbial fermentation, centrifugation, tangential flow filtration, column chromatography.

Project Management

Qualifications:

  • Degree : Bachelor's degree in business, marketing, or related field
  • Certificate: NA

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.

Experience Required: 4+ years

Shift: Day