Manufacturing Technician II

.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.
* 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 certifications and qualifications for the assigned work area.
* Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
* Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.
* 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
* High school graduate, vocational school graduate or equivalent
* 1 Year of experience in a pharmaceutical or cGMP regulated environment
* Prior production experience
* Experience working in a LEAN manufacturing environment
* Knowledge of cGMPs and FDA policies/procedures
** RESILIENCE
* * is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and ILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes.

By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.
** Please Note** – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.
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