Manufacturing Technician II - Formulation

Resilience US, LLC; Olde West Chester (OH); Presencial; USD 30.000 - 44.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) with company match

Paid vacation

Paid holidays

Tuition reimbursement

Descripción de la vacante

Resilience, Inc. is seeking a Manufacturing Technician II to support Formulation operations on the production floor. You will operate equipment, execute batches, perform in-process checks, and maintain batch records in a cGMP environment.

You will work with mechanics and lead technicians to resolve production issues, monitor materials and line performance, and assist with lean initiatives and OEE data tracking. Strong attention to detail and teamwork are essential.

Formación

• Prior experience in a regulated manufacturing environment.
• Experience with automated and semi-automated equipment.
• Ability to read, write, speak, and understand English.
• Ability to complete batch records and logbooks with attention to detail.
• Ability to follow SOPs and work instructions with minimal supervision.
• Ability to work effectively in a fast-paced production environment.

Responsabilidades

• Perform start-up, equipment operation, batch execution, material handling, cleaning and line clearance to maintain cGMP.
• Collaborate with mechanics and lead technicians to resolve production issues.
• Monitor process execution, materials, and supplies; coordinate batch execution tasks.
• Perform cleaning-in-place and steam-in-place per SOPs.
• Set up and create single-use connections, including single-use bags.
• Conduct filter integrity testing per SOP.
• Do parts washing and dispensing as needed.
• Assemble, disassemble and sanitize equipment.
• Operate pumps, mixers and other equipment, automated or semi-automated.
• Assist preventive maintenance procedures as required.
• Support lean activities and 5S; track performance data for OEE.
• Perform inventory control using SAP.

Conocimientos

Attention to detail

Teamwork

Problem solving

English language skills

Educación

High school diploma or equivalent

Herramientas

SAP

Veeva Vault

Descripción del empleo

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 is 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. The Manufacturing Technician II reports to a Supervisor/Manager, Manufacturing and supports Formulation operations. The Technician operates equipment, performs in-process monitoring, line clearances, OEE data collection, and batch record entries per cGMPs.

Job Responsibilities

• Perform start-up, equipment operation, batch execution, material handling, cleaning, housekeeping, and line clearance activities as required to maintain a cGMP environment.
• Work collaboratively with mechanic technicians and lead technicians to resolve production-related issues such as batch set-up, execution, documentation, equipment operations, SOPs, and safety and quality inspection procedures.
• Monitor process execution, material, and supply levels to ensure successful operations on the production floor; coordinate production tasks such as batch execution.
• Perform clean in place and steam in place of process lines per SOPs.
• Perform, set up, and create single-use connections including single-use bags.
• Perform and execute filter integrity testing as needed per SOP.
• Perform parts washing and dispensing operations as necessary.
• Assemble, disassemble, and sanitize equipment.
• Operate automated and semi-automated equipment (pumps, mixers, etc.).
• Assist technical staff with preventive maintenance procedures as required.
• Support lean activities including 5S, problem-solving, process improvement analysis, and manual tracking of performance data for OEE data tracking.
• Perform inventory control using SAP.

Documentation & Compliance

• Complete batch record and GMP documentation entries, including mathematical computations.
• Follow job-related safety procedures including PPEs, LOTO, ergonomics, material handling, chemical/waste/spill controls, and human safety.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures and OSHA requirements and guidelines; report all discrepancies to process facilitators.

Training & Development

• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Cross-train and support other work areas as needed.
• Attend and actively participate in daily tier meetings.

Experience & Education

Minimum Qualifications

• Prior experience in a regulated manufacturing environment.
• Working knowledge of automated and semi-automated equipment (pumps, mixers, etc.) as well as light material handling equipment.
• Ability to effectively read, write, speak, and understand English to follow detailed instructions and communicate with team members.
• Demonstrated attention to detail with the ability to accurately complete batch records, logbooks, and other controlled documentation.
• Basic problem solving and mathematical skills, including the ability to perform routine calculations (e.g., weights, measures, conversions).
• Ability to follow SOPs, written procedures and work instructions with minimal supervision, escalating issues as needed.
• Ability to identify deviations or inconsistencies in processes or documentation.
• Ability to work effectively as part of a team in a fast-paced production environment.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Working knowledge of cGMP principles, including documentation practices, safety procedures, and compliance expectations.
• Experience working in a lean manufacturing environment.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

Physical & Work Environment

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 terminals, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc. Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing. Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc. All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. Ability to pass eye exam during onboarding.

Work Schedule

Work Schedule [examples: 8 hours - Monday- Friday; 10 hours - Monday-Thursday; 12 hour - 2/2/3] The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

Sponsorship or support for work authorization, including visas, is not available for this position.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer.

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.

Salary & Benefits

• 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.
• Annual cash bonus program
• 401(k) plan with a generous company match
• Health care (including medical, dental and vision)
• Family building benefits
• Life and disability insurance
• Paid vacation
• Paid holidays
• Other paid leaves of absence
• Tuition reimbursement
• Support for caregiving needs

Company Overview

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.