Sr. Manufacturing Technician

Role Summary

Sr. Manufacturing Technician role in Framingham, MA. This 12-hour rotating position in a large-scale cGMP biologics facility involves leading a team through plant start-up from Operational Commissioning/Shakedown to process validation and commercial operations.

Responsibilities

• Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.
• Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
• Follows verbal and written procedures in operating production and equipment and performing processing steps; accurately completes appropriate production documentation.
• Maintains cleanliness and orderliness in process area.
• Ensures production area is stocked with supplies.
• Performs SOP revisions and work order generation.
• Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSIT, Validation, etc.
• Utilizes manufacturing knowledge to improve process operations and affect positive change.
• Demonstrates ability to troubleshoot basic mechanical operations.
• Effectively utilizes Microsoft Office applications.
• Mentors less experienced operators.
• Performs in process analytical testing.
• Demonstrates general knowledge of automation systems (INFOR, MES, ERP, DeltaV).
• Demonstrates general knowledge and practice of aseptic techniques.
• Supports plant floor continuous improvement initiatives.
• Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

Qualifications

• Required: High School diploma/GED with 1–3 years in a cGxP manufacturing environment, or Biotech Certificate or Biotech associate's degree with no prior experience.
• Preferred: Bachelor's degree in Biotech with no prior experience. Effectively uses process automation systems to operate production processes (i.e. DeltaV).

Skills

• Strong understanding of GMPs and manufacturing documentation processes.
• Proficiency with Microsoft Office applications.
• Ability to troubleshoot basic mechanical operations.
• Familiarity with process automation systems (e.g., DeltaV, INFOR, MES, ERP).
• In-process analytical testing experience.
• Knowledge of aseptic techniques.
• Mentorship and coaching of less experienced operators.

Additional Requirements

• Ability to lift up to 50 lbs.
• Ability to stand on average 10 hours per shift.
• Ability to gown and gain entry to manufacturing areas.
• Ability to work a twelve hour rotating shift and every other weekend, including holidays as scheduled.