Senior Manufacturing Engineer
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.
- 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
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.