Senior Manufacturing Technician

Role Summary

Senior Manufacturing Technician role in Framingham, MA within a 12-hour rotating shift at a large-scale cGMP biologics facility. Lead a team during plant start-up from commissioning through process validation and commercial operations, performing complex tasks under general guidance in accordance with manufacturing instructions and GMPs.

Responsibilities

• Maintains a safe working environment and reports incidents to Manufacturing management.
• Demonstrates understanding of GMPs as they apply to responsibilities.
• Follows verbal and written procedures in operating production equipment and processing steps; completes appropriate production documentation.
• Maintains cleanliness and orderliness in process area.
• Ensures production area is stocked with supplies.
• Performs EWI (Electronic Work Instruction) 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.

Qualifications

• Required: High School diploma/GED with 1-3 years in cGxP manufacturing environment, or Bachelor's degree with no prior experience.
• Preferred: Biotech Certificate or Associate's degree with 1-3 years of experience in a cGXP environment, or Bachelor's degree with 1-2 years of experience.
• Effectively uses process automation systems to operate production processes (e.g., DeltaV).

Education

• High School diploma or GED; or Bachelor's degree.
• Biotech certificate or Associate's degree (preferred).

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.