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

Operations

• Operate and maintain various manufacturing and packaging equipment to routinely achieve production standards while following GMPs and SOPs.
• Complete effective line clearance, cleaning and inspection including the completion of required documentation.
• Complete basic equipment set up.
• Maintain and transport all required processing equipment, materials, supplies and products needed to support manufacturing and packaging.
• Perform and document equipment challenges per current procedures.
• Complete in-process product quality checks and inspections supporting the product manufacturing and packaging, validation, and development processes as required.
• Identify equipment malfunctions and process issues; communicate and escalate appropriately for timely resolution to minimize downtime.
• Perform basic troubleshooting of equipment.
• Complete all process related documentation promptly and accurately to meet data integrity requirements.
• 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.
• Assist in the daily coordination of manufacturing and packaging activities to ensure production schedules are adhered to and customer needs are met.
• Anticipate non-equipment related production issues and act proactively to prevent occurrence or mitigate potential impact to production.
• Maintains and transports all required processing equipment, materials, supplies and products needed to support manufacturing and packaging.
• Carry out the Manufacturing Division site mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule.

Compliance

• Conducts all manufacturing and packaging operations in accordance with current Good Manufacturing Practices (cGMP), site Standard Operating Procedures (SOPs) and Divisional policies and guidelines.
• Strictly adheres to all site policies on personal conduct and attendance.
• Follow health and safety policies, including proper gowning procedures and the use of safety equipment.
• Take accountability for personal and others' safety by reporting and resolving unsafe conditions.
• Promptly identify and report any compliance, environmental, safety, and process deviations as appropriate and escalate to appropriate personnel.
• Actively participate in and complete EHS and quality-related compliance training in a timely manner.
• Maintains work area in constant state of compliance with respect to proper housekeeping, material segregation, and personal gowning including required personal protective equipment.
• Document manufacturing and packaging activities in accordance with Good Documentation Practices including ensuring data integrity requirements are met.
• Conducts routine production documentation reviews to ensure adherence to Good Documentation practices and Right First-Time production execution.
• 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

• Collaborates with peers and other employees at various levels throughout the organization to achieve company, site and departmental goals.
• Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.
• Participate in quality and safety investigations, improvement activities, and projects to improve manufacturing and packaging operation processes.
• Attends and actively participates in safety & housekeeping walkthroughs, 5S, GEMBA, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives, as required.
• Participates in projects to enhance manufacturing and packaging equipment functionality and operational processes.
• Train, develop, and mentor other team members by sharing experiences and best practices.
• Help to develop and improve process standard work.
• Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team.
• Routinely demonstrates leadership and conflict-resolution ability.

Skills

Education Requirements

• High School Diploma or equivalent.

Required Skills

• More than 2 years of experience in a GMP manufacturing facility.
• Robust understanding of cGMP requirements related to manufacturing and packaging execution.
• Demonstrated ability to work independently as team member.
• Demonstrated good attitude, interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment.
• Demonstrated ability to work with computerized and automated systems.
• Must be willing and able to lift 50 lbs.
• Must be willing to work irregular hours to support multi-shift operation and/or weekends as needed.

Preferred Skills

• Demonstrated leadership ability, peer training experience, and productivity improvement execution strongly preferred.
• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies.
• SAP / MES / electronic logbook basic knowledge from a production execution perspective.
• Outstanding communication skills both within direct team and across multiple shifts to ensure success.