Manufacturing Technician III, Formulation (Day 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

The Manufacturing Technician III reports to a Process Execution Team (PET) Area Manager on the manufacturing floor, which supports sterile operations. This position will require working in various controlled/non-classified and classified areas, operating equipment, performing in-process monitoring, conducting line clearances, collecting OEE data, carrying out cosmetic inspections, performing cleaning tasks, and completing batch record entries in accordance with cGMPs.

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.

• 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.

• 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 the Area Manager.

Minimum Qualifications
1. Significant experience in a pharmaceutical or cGMP regulated environment
2. Must be able to effectively understand, read, write, communicate and follow

instructions in the English language.

3. Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations

Preferred Qualifications
1. High school graduate, vocational school graduate or equivalent
2. Prior production experience
3. Prior Aseptic Manufacturing Experience. Knowledge of cGMPs and FDA policies/procedures

This position may also include the following conditions:

• 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 Area Manager 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

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without