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.

For more information, please visit www.resilience.com

This position requires working in various Controlled/Non-Classified areas. The Manufacturing Technician II operates equipment such as parts washers and autoclave, inspects, cleans, and sterilizes equipment, assembles/disassembles equipment, performs area cleanings in accordance with cleaning schedule, and completes batch record entries.

• Perform the duties of operating assigned machinery consisting of parts washers and autoclaves, etc.
• Responsible for assembling, disassembling, wrapping, operating, and rinsing/sanitizing various equipment.
• Perform set-up activities including but not limited to cleaning/stocking of area, spraying items through airlock, setting up parts wash and autoclave loads per SOP/Form.
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Perform visual inspections of equipment for cleanliness as specified per SOP. Must obtain visual inspection training certification.
• Obtain knowledge to be able to print off SOP's/Forms via ECMS.
• 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.
• Become aseptically qualified to enter the aseptic core area to unload autoclaves and component processing.
• Responsible for outgoing quality level.
• Obtain a novice to intermediate level of knowledge of SAP inventory movements and inventory management such as moving items from one storage location to another and goods issuing items to process orders as required.
• 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.
• Ability to use material handling equipment such as walk behind or Walkie Stacker.
• Must obtain lift truck certification.
• Support lean activities by participating in 5S and other process improvement activities.
• Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Be flexible in training and supporting other functional areas as needed.
• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
• Send out pass down communications as required.
• May be required to become media qualified to assist with production activities in other functional areas.
• May be required to obtain cold room training/access to be able to transfer materials in and out of the cold rooms.
• May be required to take proper training to become certified trainer within the area.

Minimum Qualifications

* 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

* 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

• Work is performed in Controlled/Non-Classified and Classified (cleanroom) production areas requiring aseptic gowning. This is primarily a non-Sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP.

• Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.

• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.

• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.

• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

• Ability to pass eye exam during onboarding.

12 Hour - 2/2/3 Day Shift (6am-6:30pm)

The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

Sponsorship or support for work authorization, including visas, is not available for this position.

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.