Manufacturing Technician II - Filling (Nights)

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

The Manufacturing Technician II reports to a Process Execution Team (PET)/ MSAT 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 will start on a dayshift Monday-Friday 8 hour schedule. It will support the new cartridge filling line tech transfer within the MSAT team and then eventually transition to commercial operations team at the commercial handover. At the commercial handover, the position will move to a 2-2-3 12 hour shift schedule, transitioning to night shift.

Position Summary & Responsibilities

• 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 Requirements

• 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 Background

• High school graduate, vocational school graduate, or equivalent.
• Prior production experience.
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.

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.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.