Technician (Process), Operations

Job Description

POSITION OVERVIEW – Basic Functions & Responsibility Essential functions include, but are not limited to:

The Technician (Process), Operations role is an excellent opportunity for individuals with experience in manufacturing and/or packaging operations who are proficient with hands-on processing

and production control activities. This role is responsible for independently and proficiently executing daily production tasks in alignment with standard operating procedures.

Key responsibilities include following manufacturing and packaging requirements, adhering to Good Manufacturing Practices (GMP), and completing daily tasks according to established procedures under

the Operations Manager's guidance while collaborating with team members to ensure safe and timely production of high-quality products.

The process technician will operate equipment, perform basic equipment setup, execute equipment challenges, monitor equipment performance and product quality during production, clean work areas,

move materials accurately and efficiently and perform routine equipment / process troubleshooting.

This role requires a proactive individual who is not only knowledgeable about GMP standards but also excels in communication and teamwork.

The successful candidate will collaborate closely with various departments to ensure the smooth and efficient operation of our manufacturing processes and maintain high-quality standards.

PRIMARY ACTIVITIES Primary activities include, but are not limited to:

• Operations

o Operate and maintain various manufacturing and packaging equipment to routinely achieve production standards while following GMPs and SOPs.

o Complete effective line clearance, cleaning and inspection including the completion of required documentation.

o Complete basic equipment set up.

o Maintain and transport all required processing equipment, materials, supplies and products needed to support manufacturing and packaging.

o Perform and document equipment challenges per current procedures.

o Perform visual inspections of products, packaging, and production areas during line clearance, in-process checks, repackaging, and material reintroduction. These tasks require distinguishing

fine visual details, printed information, and product or component colors.

o Identify equipment malfunctions and process issues; communicate and escalate appropriately for timely resolution to minimize downtime.

o Perform basic troubleshooting of equipment.

o Complete all process related documentation promptly and accurately to meet data integrity requirements.

o Proactively identifies potential production issues and takes action to prevent occurrence.

Organize, clean and maintain the designated work area to ensure a clean and orderly working environment.

o Assist in the daily coordination of manufacturing and packaging activities to ensure production

schedules are adhered to and customer needs are met.

o Anticipate non-equipment related production issues and act proactively to prevent occurrence or

mitigate potential impact to production.

o Maintains and transports all required processing equipment, materials, supplies and products needed to support manufacturing and packaging.

o Carry out Our Company's site mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule.

• Compliance

o Conducts all manufacturing and packaging operations in accordance with current Good Manufacturing

Practices (cGMP), site Standard Operating Procedures (SOPs) and Divisional policies and guidelines.

o Strictly adheres to all site policies on personal conduct and attendance.

o Follow health and safety policies, including proper gowningprocedures and the use of safety equipment.

o Take accountability for personal and others' safety by reporting and resolving unsafe conditions.

o Promptly identify and report any compliance, environmental, safety, and process deviations as appropriate and escalate to appropriate personnel.

o Actively participate in and complete EHS and quality-related compliance training in a timely manner.

o Maintains work area in constant state of compliance with respect to proper housekeeping, material segregation, and personal gowning including required personal protective equipment.

o Document manufacturing and packaging activities in accordance with Good Documentation Practices including ensuring data integrity requirements are met.

o Conducts routine production documentation reviews to ensure adherence to Good Documentation practices and Right First-Time production execution.

o Assist in the investigation, root cause determination, and CAPA implementation for personnel

related compliance discrepancies noted during day-to-day activities and/or audits. Escalate as per IPT management processes.

• Collaboration and Teamwork

o Collaborates with peers and other employees at various levels throughout the organization to achieve company, site and departmental goals.

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