Manufacturing Technician II - Filling

Initial Therapeutics, Inc.; Olde West Chester (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biomanufacturing company is seeking a Manufacturing Technician II to operate and monitor filling equipment. This role involves ensuring compliance with cGMP, maintaining quality, and executing production protocols. The ideal candidate will have strong attention to detail and experience in a regulated environment. Enjoy a competitive salary with comprehensive benefits.

Benefits

401(k) plan with company match

Annual cash bonus program

Flexibility with time off

Comprehensive healthcare benefits

Tuition reimbursement

Qualifications

• Must be able to effectively read, write, and communicate in English.
• Good attention to detail is required.
• Experience in a pharmaceutical or cGMP regulated environment preferred.

Responsibilities

• Operate assigned machinery and perform in-process monitoring.
• Responsible for cleaning and sanitizing filling equipment.
• Maintain accurate records and perform mathematical computations.

Skills

Attention to detail

Communication in English

Teamwork

Adaptability

Education

High school graduate or equivalent

Job description

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

Position Summary:

The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) 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.

**There are (2) open roles - Shift Notes below:

- Day (A) Shift - 12-Hour Rotating Schedule - 1 Position

- Day (A) Shift for 6 months and then will move to Night (C) Shift - 12-Hour Rotating Schedule - 1 position

Position 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 certifications and qualifications for the assigned work 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.
• 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
• Candidate must attain aseptic gowning qualification during training and be able to aseptically gown on a regular basis.

Preferred Qualifications:

• 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

**There are (2) open roles - Shift Notes below:

- Day (A) Shift - 12-Hour Rotating Schedule - 1 Position

- Day (A) Shift for 6 months and then will move to Night (C) Shift - 12-Hour Rotating Schedule - 1 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 equity, 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, flexible time off, 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 and the biomanufacturing revolution? 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.