Process Development Technician II Job Summary
- The Process Technician II owns and drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Operations Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.
Education & Qualifications
- Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility
- Operates buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
- Supports implementation of new technology for process execution and/or analysis.
- Interacts across the asset to achieve production schedule.
- Reviews documentation daily as well as perform data entry - Monitor, identify and communicate process and compliance trends real time.
- Archives documentation according to established procedures.
- Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
- Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
- Provides support during audits and with audit observation closure.
- Responsible for keeping training current.
- Maintains a safe working environment
- Thorough understanding of cGMP requirements and safety practices.
- Employs Automated systems, enterprise systems, and available technology to execute work.
- Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.
- Strives for Right first time execution through flawless execution and ownership of the process.
- High School diploma and 4 years of relevant experience required. or BA 2+ Yrs
- Engineer degree, Chemical Engineer helpful
- Experience in a GMP manufacturing environment is desired.
- Familiarity and experience with either purification processes or mammalian cell culture.
- Support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) is not essential, but is highly desirable.
- The ability to execute against SOP's and document entries in a cGMP compliant manner.
- Ability to interpret and prioritize workflow to maintain the production schedule.
- Effective verbal and written communication skills.
- Support Media Formulation
- Media Formulation experience needed
- Manufacturing, SOP, SIP, GMP experience
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.