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.
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The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) Process Facilitator 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.
Job 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 behaviors, 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/WES 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
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
High school graduate, vocational school graduate or equivalent
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
Prior experience in a pharmaceutical or cGMP regulated environment
Prior experience using an isolator
Good understanding and experience in aseptic process and technique
Prior production experience (Filling area)
Experience working in a LEAN manufacturing environment.
Knowledge of cGMPs and FDA policies/procedures.
This position may also include the following:
This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
Visual acuity (such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.)
Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.
Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
Close quarters, narrow passageways, crawl spaces, shafts, manholes, small enclosed rooms, small sewage and line pipes.
Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).
The items described here are representative of those that must be met to successfully perform the essential functions of this job.
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 - $30.50 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.
RESILIENCE (National Resilience, Inc.), is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans
