Sr. Manufacturing Technician

Role Summary

This is a 12 hour, rotating position in a flexible, single-use technology, large scale cGMP biologics facility. Initial job responsibilities will include leading a team responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation and commercial operations. The Sr. Manufacturing Technician will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

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 (e.g., DeltaV).

Skills

• Demonstrates ability to operate production processes and use process automation systems.
• Ability to mentor less experienced operators.
• Proficient with Microsoft Office applications.

Education

• High School diploma or GED; Biotech Certificate or Biotech associate's degree; Bachelor's degree in Biotech (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.