Technician, Operations (Operator w/Mechanical Skill)

MSD

About The Position

POSITION OVERVIEW – Basic Functions & Responsibility Essential functions include, but are not limited to: The Technician (Technical), Operations role is an excellent opportunity for individuals with experience in manufacturing and/or packaging operations who are proficient with basic mechanical/electrical equipment troubleshooting, maintenance, and repair. This role will serve as the first responder to challenges that arise with manufacturing and packaging equipment, effectively diagnosing and addressing technical issues. 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 Technician (Technical) position will operate equipment, setup equipment, perform equipment challenges, monitor quality during production, clean work areas, and move materials accurately and efficiently. The position will also have responsibilities including routine and non-routine equipment / process troubleshooting, process monitoring, and alarm response, all aimed at maintaining operational efficiency and product quality. This position requires a proactive individual with strong technical skills, exceptional attention to detail, and the ability to think critically under pressure. The successful candidate will play a pivotal role in enhancing the operational integrity of manufacturing and packaging processes, contributing to the production of high-quality products in a safe and efficient environment.

Requirements

High School Diploma or equivalent
More than 2 years of experience in a GMP manufacturing facility.
Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment.
Basic mechanical and electrical system understanding
Demonstrated ability to troubleshoot equipment utilizing a systematic approach to understand problems and determine appropriate solutions.
Demonstrated ability to work independently as team member.
Demonstrated ability to work with computerized and automated systems.
Must be willing and able to lift 50 lbs.
Must be willing to work various shifts.
Must be willing to work irregular hours to support multi-shift operation and/or weekends as needed.

Nice To Haves

Maintenance experience within a GMP regulated environment
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 of overall team.

Responsibilities

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.
Setup and adjust the equipment by using appropriate tools to ensure proper alignment and proper clearances.
Maintains and transports 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 testing and inspections supporting the manufacturing and packaging, validation, and development processes as required.
Act as first responder to equipment malfunctions and process issues; diagnose issues, make necessary adjustments to return the equipment to a functional state.
Escalate any unresolved line issues per established guidelines to ensure efficient operations performance.
Proactively identifies potential production issues and takes action to prevent occurrence.
Assist maintenance personnel with routine and non-routine equipment maintenance and repairs, including helping with performing maintenance tasks, initiating work orders and retrieving parts from the stockroom as required.
Cleans and lubricates machines periodically and performs other basic maintenance work required (ie. wiping off sensors, recharging process fluids, etc.) to assure the efficient operation of all equipment.
Organize, clean and maintain the designated work area to ensure a clean and orderly working environment.
Carry out the Manufacturing Division site mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule.
Conducts all manufacturing and packaging operations in accordance with current Good Manufacturing Practices (cGMP), site Standard Operating Procedures (SOPs) and Divisional policies and guidelines.
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.
Strictly adheres to all site policies on personal conduct and attendance.
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
Document equipment changes per cGMP procedures within appropriate system.
Assist in the investigation, root cause determination, and CAPA implementation for equipment related compliance discrepancies noted during day to day activities and/or audits.
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 other team members regarding the basic response for common faults and errors.
Help to develop and improve setup and troubleshooting standard work.
Pursue knowledge and skills in assigned area from an operations and equipment maintenance perspective and share that information readily with team.
Actively identifies and drives problem resolution and implements feasible solutions for opportunities and issues identified by the team.
Participate in new equipment installations by interfacing with equipment vendors, partnering with project engineering on testing/qualification activities, recommending spare parts, and assisting with the review of preventative maintenance plans.