Manufacturing Technician / Operator

The Fountain Group; Hillsboro (OR); On-site; USD 30,000 - 34,000; Full time

Job summary

The Fountain Group is seeking a Manufacturing Technician / Operator for a Hillsboro, OR site. This is a 1-year contract, onsite, focused on filling, inspecting, and packaging sterile products in an automated facility compliant with cGMPs.

Pay is $23/hr W2, with a 4-day work week (3pm–1:30am) and potential for temp-to-perm based on performance. You will troubleshoot and maintain production equipment, assist engineers, and manage documentation and material movements using SAP and MES.

Qualifications

• High School Diploma or GED required; Associate degree preferred.
• 2+ years in manufacturing; GMP highly preferred.
• Experience in packaging settings highly preferred.
• 2–5 years operating equipment for inspection/packaging of products.
• Computers: interface with computer systems and PLC-based logic.
• Proficient with Microsoft Word, Excel, PowerPoint; basic typing skills.

Responsibilities

• Adhere to plant safety policies and identify unsafe conditions.
• Assist in cleaning, setup, changeover, and running equipment for inspection/packaging of vials, syringes, and devices.
• Support Engineers/Maintenance in repair, maintenance, and calibration of GNE Systems; include routine maintenance.
• Train other Technicians and help develop SOPs and training materials.
• Execute production recipes, check-in equipment, and perform material movements using SAP and MES.
• Document start/finish of manufacturing, ensuring traceability of components and finished product.
• Identify, report deviations per SOPs; ensure data integrity.
• Knowledge of SAP, MES, PiProcess Book, PLC, and HMI automation systems.
• Troubleshoot mechanical failures and perform inspections of filled product vials.
• Perform environmental monitoring and housekeeping per GMP requirements.
• Report equipment and process concerns at shift start/finish to improve reliability.

Skills

GMP experience

Equipment operation

Computer literacy

MS Office

Packaging

Manufacturing

PLC interface

Education

High School Diploma or GED

Associate degree preferred

Tools

SAP

MES

PLC

Job description

The Fountain Group is currently seeking a Manufacturing Technician / Operator for a prominent client of ours. This position is located in Hillsboro, OR (100% Onsite). Details for the position are as follows:

Job Description:

• Payrate: $23/hr W2
• 1 year contract. Temp to perm possibility based on performance.
• Shift: Mon – Thurs; 3pm to 1:30am (10hr, 4 days a week)
• Must be comfortable gowning (PPE).

Required Skills:

• High School Diploma or GED is required. Associate degree preferred.
• 2+ years of experience in a manufacturing industry background. GMP highly preferred.
• Exp working in a packaging setting is highly preferred.
• 2 to 5 years (within the last 7 years) experience in the operation of equipment used in the inspection and packaging of products/containers is highly desirable.
• Computers: Must be computer literate, including ability to interface with computer systems and PLC-based logic.
• Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. Must possess basic typing skills.

Main Purpose of the Position:

• Under the direction of the Process Unit Lead or Lead Technician, perform a wide variety of tasks and operations that are required to fill, inspect and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility.
• Troubleshoot, maintain, and assemble all production equipment as required. Assist Engineers and Maintenance Mechanics on major equipment overhauls, repairs, and installations as necessary.
• All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and client standards.
• In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits and capabilities:
• Passion and drive to develop and maintain a culture of continuous improvement, dedicated to providing the best results for our internal and external customers.
• Embraces Lean Manufacturing/Six Sigma tools (e.g., 5S, Kaizen) and leverages data analytics of system performance to identify opportunities for improvement and deliver reduced costs and increased efficiency.
• Collaborates with Cross-Functional teams (Quality, Engineering, Assets) to pilot new process enhancements.
• Actively participates in a teamwork environment that maintains a high performance culture.
• Strictly adhere to Good Documentation Principles (GDP's), and the ability to accurately complete Batch Production Records (BPRs), logbooks, and forms to maintain a high level of data integrity.

Responsibilities:

• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• Assist in cleaning, set up, change over, and running of equipment for the inspection or packaging of various-sized vials, pre-filled syringes, and devices as required.
• Supporting the Engineers, Maintenance Mechanics, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required. This includes executing user-performed and routine maintenance.
• Perform training of other Technicians, and assist in the development and improvement of HTO SOP's and training materials.
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
• Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
• Responsible for identifying, reporting, and documenting process deviations or atypical events in accordance with site Standard Operating Procedures (SOPs)
• Knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), PiProcess Book, Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI).
• Troubleshooting and identification of resolution for mechanical failures in production.
• Performing manual and semi-automated inspection of filled product vials with a focus on quality and efficiency.
• Conduct environmental monitoring activities in the manufacturing areas as required including routine cleaning and housekeeping activities to maintain environmental grade of each manufacturing area.
• At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.