Manufacturing Technician IV, Lead - Device Assembly (Blue Ash - NIGHT SHIFT)
Blue Ash, United States of America
About the role
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 The Manufacturing Technician IV, Lead reports to a Supervisor/Manager on the Manufacturing floor and leads complex Packaging floor activities. The Technician serves as a technical resource for
the team, performs advanced-level documentation review, drives continuous improvement, and collaborates with Management and Engineers to ensure compliant and efficient packaging operations. Job
Responsibilities Operations Lead and monitor complex process activities to ensure successful operations on the production floor. Perform technician tasks as required including start-up, equipment operation, manual packaging, and line clearances. Perform inventory control and reconciliation activities using SAP and WES. Execute protocols as required as part of equipment qualification and process validation work. Ensure work
requirements are followed on the production floor in accordance with SOPs and cGMPs. Support lean activities including 5S, problem-solving, and serving as CI project resource. Documentation & Compliance Perform advanced-level batch record and GMP documentation entries on the production floor, including complex or non-routine documentation; provide guidance to team members on documentation accuracy. Review process documents such as operational SOPs, forms, and batch records for accuracy. Maintain all required certifications and
qualifications for the assigned work area. Training & Development Serve as a technical resource for
the team, providing subject-matter support to production and mechanical technicians. Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members. Collaborate with Management and Engineers on packaging floor initiatives. Apply strong problem-solving and prioritization skills to make independent decisions and provide guidance to team members on daily operational activities. Acquire and maintain all required certifications and
qualifications for the assigned work area. Attend and actively participate in daily Tier 0 meetings. Experience & Education Minimum
Qualifications Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment. Advanced knowledge of cGMP
requirements and quality systems, including deviations, change control, and data integrity. Demonstrated ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members in a fast-paced production environment. Proven ability to review and ensure accuracy of critical GMP documentation and batch records. Demonstrated ability to work with limited supervision and independently determine daily priorities, with strong organizational, analytical, and problem-solving skills to make informed decisions under pressure. Applied quantitative skills sufficient to interpret production data, evaluate trends, and support investigations and continuous improvement work. Experience providing on-the-job training to peers in a manufacturing environment. Ability to effectively read, write, speak, and understand English to communicate technical information cross-functionally. 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. 4+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment. Prior experience serving as a subject-matter resource or trainer on the production floor. Experience 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 terminal, 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 Night Shift: 6pm - 630am with 2 nights on, 2 nights off, 3 nights on, 3 nights off. 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. 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 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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $26.00 - $40.50 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? We encourage you to apply and start a conversation with one of our recruiters. Join Our Talent Community Don't see a posting that's the right fit? Join our talent community to be considered in our talent pool and we'll reach out if the right opportunity arises. 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. Culture Focus Sites
