Manufacturing Technician II - PET (Dayshift)

Resilience; Kentucky; On-site; USD 40,000 - 55,000; Full time

Job summary

Resilience in Kentucky is seeking a Manufacturing Technician II to operate and monitor filling machinery, perform quality checks, and maintain GMP compliance. This position is crucial for supporting the filling operations and includes responsibilities such as data entry, cleaning, and documentation. Candidates should have attention to detail and prior manufacturing experience, ideally in a pharmaceutical or regulated setting. A high school diploma is preferred. Join Resilience and be part of an innovative biomanufacturing team dedicated to improving patient access to complex medicines.

Qualifications

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

Responsibilities

• Operate and monitor filling machinery.
• Perform cleaning and housekeeping activities.
• Maintain GMP documentation entries.
• Assist in preventive maintenance procedures.

Skills

Attention to detail

Ability to follow instructions

Mathematical calculations

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.For more information, please visit**Position Summary & Responsibilities**This position: The Manufacturing Technician II reports to a Process Execution Team (PET) 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 is a dayshift position from 6:00 AM - 630PM.***This position may also include the following conditions:** 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 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. • Prior production experience. • Experience in a pharmaceutical or cGMP regulated environment. • 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 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.**RESILIENCE** is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.**Please Note** – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.