Manufacturing Technician II-Device Assembly (Night Shift)

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.

For more information, please visit www.resilience.com

Job Description

Position Summary & Responsibilities

This position will require working in various Controlled/Non-Classified areas. The Packaging Technicianperforms a variety of manufacturing tasks (operates equipment, performs in-process monitoring, lineclearances, cosmetic inspection, cleaning and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) to achieve aprescribed level of purity, quality, and consistency in product and work output in accordance with cGMPs.

**This role will be on a 2-2-3 shift schedule (12 hours, Night shift, 6 PM to 6:30 AM) **

Position Responsibilities

* Perform the duties of operating assigned machinery consisting of servicing machines withmaterials, monitoring equipment status, reintroduction of materials, manually palletizing finishedmaterials, and assuring a smooth flow of product.

* Be able to start-up machinery including equipment set-up, perform recipe selection and data entry on manufacturing computerized system (SCADA and HMI), make minor adjustments, andperform critical sensor challenges.
* Perform manual packaging tasks as required including hand packaging and rework of in-process
and finished material.
* Operate light material handling equipment (motorized and manual pallet jacks, non-motorizedlifts) as the need arises to safely move, store or deliver material to the proper location.
* Perform visual quality inspection and sampling of in-process materials. Promptly escalateconcerns to Lead and Process Facilitator as needed.
* Perform minor troubleshooting including clearing minor jams and identifying equipment defects.Work collaboratively with technical resources to resolve equipment issues as needed.
* Perform inventory control and reconciliation activities, which may require the use of SAP andWES in a limited role.
* Perform cleaning, housekeeping and line clearance activities for assigned areas to maintain acGMP environment. This includes assembling, disassembling, and sanitizing various packagingequipment.

* Perform batch record and GMP documentation entries. Perform mathematical computation asneeded.
* Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO,human safety, material handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.
* Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs andestablished safety and quality procedures.
* Support lean activities and process improvement work such as performing 5S in the work area,participating in problem-solving, and manual tracking of performance data for OEE and processimprovement analysis.

* Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train andconduct evaluations on other team members for training qualifications.
* Review process documents such as operational SOPs, forms, and batch records for accuracy.
* Identify and provide suggestions for process improvement while maintaining quality and cGMPcompliance as opportunities arise.
* Execute protocols as required as a part of equipment qualification and process validation work.
* Be flexible and support other work areas within the Manufacturing Team as needed.
* Perform all other assigned duties with minimal supervision under the direction of the processfacilitator or designee as needed.
* Acquire and maintain all required certifications 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
* Experience in a pharmaceutical or cGMP regulated environment
* 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

Preferred Qualifications
* High school graduate, vocational school graduate or equivalent
* Working knowledge of Microsoft applications and SAP
* Prior production experience
* Experience working in a LEAN manufacturing environment
* Knowledge of cGMPs and FDA policies/procedures

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.