Manufacturing Technician II

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Position Summary & Responsibilities

The Manufacturing Technician II reports to a Process Execution Team (PET)
Supervisor/Manager on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified and Classified areas. The Filling Technician
operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs.
** This position operates on a 2-2-3 schedule, 12 hours shifts.
Night Shift position working 6:00 pm - 6:30 am, Day shift position working 6:00 AM
-630PM.

This position may also include the following conditions:

* Perform the duties of operating assigned machinery consisting of servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product.

* Responsible for assembling, disassembling, operating and sanitizing various Filling equipment.

* Perform and execute filter integrity testing as needed per SOP

* Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.

* Be able to start up and make minor adjustments to machinery

* Computer on-line may require some data input. This includes SCADA and HMI entries.

* Perform visual and physical checks of in-process and finished materials as requested.

* Work with various printing devices including printing mats.

* Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed

* Knowledge of product security controls and material handling equipment.

* Responsible for outgoing quality level

* Understand aseptic behaviours, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment

* Perform inventory control and reconciliation activities, which may require the use of SAP in a limited role

* Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines.

* Be familiar with "Material Safety Data Sheets" for area chemicals

* Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.

* Assist mechanical staff with preventive maintenance procedures, as required.
* Support lean activities and process improvement work such as performing 5S in the work area and Single Minute Exchange of Die (SMED), participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.

* Assist with executing Validation/Engineering protocols for processes/equipment.

* Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise

* Be flexible in training and support other Filling functions as needed.

* Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.

* Acquire and maintain all required certification and qualifications for the assigned work area.

* Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team.

* Ability to work effectively in a team environment

* Candidate should possess the ability to work in and adapt to a changing/demanding environment.

* Some-overtime may be required with minimal advance notice to support business needs

Minimum Qualifications

* Must have the ability to…