About our client:
Our client is an acute care specialty pharma company based in San Diego. They specialize in a technology that provides sustained-release delivery of medications for post-surgical pain. Our client has two marketed products that are used by professionals in the healthcare industry. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.
Job Responsibilities:
1) Provide process and equipment engineering capabilities and experience to the Technical Operations Project Team
2) Focus on the design and scale-up of new manufacturing equipment and monitoring procurement activities
3) Handle equipment fabrication, factory acceptance testing, site installation, site acceptance testing, start-up and validation
4) Work independently and use good judgment in carrying out functions
5) Provide process engineering design support services for the scale-up and commercialization of new products
6) Produce and review design drawings including PFDs, UFDs, and P&IDs
7) Supervise external engineering consultants
8) Provide process overview
9) Review drawings and documents produced by support groups
10) Provide key input into validation of process equipment and associated utilities, including generation of validation plans and protocols
11) Guide Manufacturing and Operations staff in the execution of validation protocols
Job Requirements:
1) BS in Engineering (Chemical Engineering preferred)
2) 2 – 5 years of experience in relevant equipment, clean utility and process systems
3) Minimum 2 years of experience in pharmaceutical/biotech industry
4) In-depth understanding of pharmaceutical manufacturing equipment and supporting utility systems (sanitary and sterile operations)
5) Knowledge of and experience in working in cGMPs environment
6) Knowledge of process control
7) Excellent applied problem-solving skills
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02909.html
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