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Company Contact Info
- Sylmar California, CA
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Apex Systems • Sylmar California, CA
Posted 28 days ago
- Evaluation of production equipment
- Production support and process validation
- Troubleshoot manufacturing process and equipment
- Protocol and report writing
- Generate and modify manufacturing process documentation
- Work with cross functional teams as required
- Develop and implement process improvements
- BS/MS in Chemical/Biochemical Engineering, Mechanical Engineering, Biomedical Engineering, or Science
- Bachelor's Degree 1-3 years of Engineering or Operations experience OR a Master's Degree + 1 years of Engineering or Operations experience.
- Process/equipment development and optimization experience,late stage or commercial products experience with strong focus on manufacturing support.
- Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
- Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with cGMPs, regulatory filings and compliance issues for drug product and combination devices.
- Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178