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location: Andover, Massachusetts
job type: Contract
salary: $17.73 - 20.86 per hour
work hours: 7 to 3
education: High School
- The Process Technician supports the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule.
- The Process Technician will work on interdisciplinary teams, to implement process improvements, participate in process troubleshooting.
- Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves.
- Supports the implementation of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
- Strives for Right first time execution, the timely review of daily documentation and supports data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.
- Implements any audit observation improvements.
- View Role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc. ·
- Responsible for remaining current on training programs in support of manufacturing processes.
- Supports Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas. · Interacts with manufacturing asset in support of manufacturing campaigns. ·
- Assists in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
- Escalates the need for work requests when issues arise with manufacturing equipment.
- Adequate in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
- Assists production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence.
qualifications: MINIMUM QUALIFICATIONS
- High School diploma required.
- Experience in a GMP manufacturing environment is desired.
- Familiarity and experience with Support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens).
- 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
- Requires the moving of heavy equipment and the ability to lift ~50 pounds. The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.
- 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.
skills: SOP, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice), Manufacturing Operations
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.