Manufacturing Technician II

Role Summary

This manufacturing role is responsible for executing all production processes in the manufacturing area while following cGMP, environmental health and safety guidelines, and related regulations. The role involves hands-on work with manual tasks and operation of automated equipment, and participation in departmental projects and quality teams. Under supervision, the technician performs hands-on execution of activities, can initiate minor document revisions, troubleshoot simple procedures, and contribute to continuous improvement initiatives.

Responsibilities

• Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
• Support all local manufacturing operations.
• Complete relevant paperwork following GDP/GMP guidelines.
• Perform hands-on execution of manual and automated manufacturing operations, working with equipment such as Centrifuges, Filter Presses, Ultrafiltration systems, CIP/COP, Nanofiltration Skids, Chromatography Columns, and material handling devices; manual activities include weighing, chemical additions, paste suspension, cleaning, disassembly/assembly, connections, titrations, and related tasks.
• Receive and distribute supplies into the production area as necessary.
• Perform removal of hazardous waste per safety guidelines.
• Troubleshoot minor process problems and respond to process alarms.
• Communicate safety, quality, compliance, and equipment issues to the manufacturing lead operator and supervisor.
• Participate in the training of team members on the manufacturing floor.
• Participate in the revision and review of pertinent documentation as appropriate.
• Participate in Safety and Continuous Improvement Teams.
• May perform other duties as assigned.

Qualifications

• Required: High school diploma or GED plus 1+ years of related experience or AA or higher with no prior experience required.
• Required: General working knowledge of related manufacturing techniques and specialties.
• Required: Basic Automation experience using DeltaV, Electronic Batch Management, PLC, etc.
• Required: Familiarity with pharmaceutical production equipment including centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place).
• Required: Must have good communication skills in English (verbal and written) and understanding of cGMP regulations in a pharmaceutical manufacturing environment.
• Required: Must be able to read and follow detailed written procedures.
• Required: Proficient in a variety of mathematical disciplines and able to work with metric and USA measurement standards.
• Required: Good interpersonal skills and ability to work effectively in a team environment.
• Required: Knowledge of basic chemical and biological safety procedures.
• Required: Good computer skills.

Skills

• Operating and troubleshooting automated equipment and control systems (DeltaV, PLCs, EBM)
• Basic process troubleshooting and alarm handling
• Reading and following SOPs, specifications, and batch records
• Effective communication and teamwork
• Safety-conscious with attention to cGMP compliance

Education

• High school diploma or GED; AA or higher accepted

Additional Requirements

• Work in a controlled environment requiring gowning and protective clothing; may require additional hearing protection.
• Remove makeup, jewelry, contact lenses, nail polish, and artificial nails in manufacturing areas.
• Work in cold, wet environments; multiple shifts including weekends; may require overtime.
• Work around chemicals that may require respiratory protection.
• Ability to lift, push, pull, and carry up to 50 lbs with assistance; stand for extended periods; climb ladders and stairs while wearing gowning.
• Occasional bending, twisting, reaching, and squatting; may require confined area work and Clean Room conditions.