Great client is looking for a Senior Process Technician drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Senior Process Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.
There are multiple shifts available:
- 1st shift 8am - 4:30pm, Monday - Friday
- 2nd shift 3:30pm - 12:00am, Monday - Friday
- 3rd shift 12:00am - 8:30am, Monday - Friday
**Off-shift coverage may be required.
location: Andover, Massachusetts
job type: Contract
salary: $20 - 25 per hour
work hours: Rotating Shifts
- Executes manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
- Executes the implementation of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
- Implements the execution and issue resolution associated with process equipment commissioning, qualification and validation.
- Supports the assigned audit lead for walkthroughs/GMP100s and observation improvements.
- Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
- Responsible for remaining current and reviews curriculum for training programs in support of manufacturing processes.
- Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
- Collaborates with cross-functional manufacturing assets in support of manufacturing campaigns.
- Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
- Ensures work requests are generated when issues arise with manufacturing equipment.
- Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
- Familiarity with SAP, LWLIMS
- 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.
- The incumbent is required to attain detail knowledge of the operational equipment.
- The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
- The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.
- process technician, SOPs CIPs, SIPs, Sanitization, GMP100s , Lean Manufacturing, Sustainability, Operational Excellence SAP, LIMS, AMPS, PDOCS and/or QTS.
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.