Manufacturing Technician II - Filling (Dayshift)

Resilience; Olde West Chester (OH); On-site; USD 29,618 - 44,083; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Comprehensive healthcare benefits

Job summary

Resilience is seeking an operator to support its new cartridge filling line in Olde West Chester, Ohio. The role involves the operation and maintenance of machinery while ensuring compliance with cGMP standards.

Ideal candidates will have prior experience in a regulated environment and strong attention to detail. Benefits include a competitive salary range of $21.50 – $32.00 per hour and comprehensive healthcare coverage.

Qualifications

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

Responsibilities

• Operate and maintain filling machines and equipment.
• Conduct inventory control and reconciliation activities.
• Support lean activities and process improvement efforts.

Skills

Attention to detail

Mathematical calculations

Education

High school graduate or equivalent

Tools

SAP

cGMP knowledge

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.

It builds 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 & Responsibilities

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 the commercial operations team at the commercial handover. At the commercial handover, the position will move to a 2‑2‑3 12 hour shift schedule, remaining on dayshift.

• 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, including 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, including 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 manually tracking 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.
• Be capable and motivated to learn new skills and develop new capabilities on an ongoing basis to contribute to the success of the Process Execution Team.
• Work effectively in a team environment.
• 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.

EEO & Accommodations

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 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.

Benefits & Compensation

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.

Resilience offers employees a robust total rewards program: an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package thoughtfully designed to support 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.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards.