Senior Manufacturing Engineer job in El Segundo, USA

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Job type: Permanent

Discipline: Manufacturing, Validation, Automation

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Sr. Manufacturing Engineer in the El Segundo, CA area with a globally leading pharmaceutical company. A successful candidate will have a bachelor's degree and extensive experience with GMPs/cGMPs, at least 7 years of pharmaceutical manufacturing, process development, and statistical analysis using JMP or Minitab within the pharmaceutical industry.

Job Responsibilities:

Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations
Work with manufacturing and process design teams to define requirements and understand functional specifications
Identify suppliers and vendors that can supply equipment that fit the specifications and requirements
Lead investigations and identify root cause for critical deviations to maintain routine manufacturing operations and determine process improvements for manufacturing
Provide a science-based approach for the resolution of deviations and process issues
Support technology transfer processes and working cross functionally between Process Development and Manufacturing department
Support projects to increase safety/compliance or improve process or equipment robustness
Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation
Participate and report to a cross-functional team to advance production activities
Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
Write and review technical documentation (batch records, SOPs, protocols & reports for equipment qualifications, comparability, and cell therapy manufacturing process validation)

Skills and Requirements:

Degree with 7-10 years of pharmaceutical manufacturing, technology transfer & process development experience required (MS Preferred)
Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
Technical writing and protocol/report writing is a plus
Experience in statistical analysis using JMP or Minitab
Knowledge of data management tools and statistical process controls
Previous experience with cell therapy products is a plus
Understand manufacturing needs and adapt to the changing needs of the manufacturing environment

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#TechOps

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