Technical Specialist Job in Middlesex 08846, New Jersey US
JOB SUMMARY:
Initiate and complete projects with minimum supervision. Design and execute technical protocols for new and existing products in support of facility validation program. Evaluate and recommend equipment, instrumentation and process chemicals to optimize production efficiency, safety, quality and compliance.
Essential Functions:
1. Works closely with facility teams and consultants to provide technical support for the execution of production validation plans for manufacturing and packaging operations.
2. Develops and prepares technical reports in support of operational projects.
3. Contributes to the development of standard operating procedures
4. Supports site investigations and implementation of corrective/preventative actions (CAPAs)
5. Interfaces with third party vendors on production projects.
6. Assists in the training of CorePharma personnel on relevant procedures and practices.
7. Works with engineering, maintenance and quality control to ensure that critical GMP utility systems, e.g. purified water and environmental control systems are maintained in a state of control. Leads/support projects associated with the purified water system, production areas, etc.
Physical Work Activities and Exposure (If required)
Must be able to work in cGMP environments and achieve respiratory protection certification.
Minimum Qualifications
B.S or B.A. in Pharmacy, Biological Sciences, Chemistry or Chemical Engineering