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West Chester Township, Ohio, United States
Onsite
Not Available
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 II reports to a Supervisor/Manager, Manufacturing and works in Controlled/Non-Classified areas, supporting Inspection operations. The Technician performs a variety of tasks including operating inspection equipment, performing visual/cosmetic/physical inspection, line clearances, OEE data collection, and completing batch record entries per cGMPs.
Operations:
Perform the duties of operating assigned inspection machinery: service automated inspection equipment, monitor equipment status, reintroduce materials, manually palletize inspected materials, and ensure smooth product flow.
Perform manual visual, cosmetic, and physical inspection of material; promptly escalate concerns to Lead and Supervisor/Manager as needed.
Start-up equipment, make minor adjustments, remove jams, perform minor troubleshooting, and perform minor assembly/disassembly for cleaning purposes.
Use material handling equipment such as motorized and manual pallet jacks and non-motorized lifts.
Transfer materials in and out of cold rooms as needed.
Perform cleaning, housekeeping, and line clearance activities for assigned areas to maintain a cGMP environment.
Support lean activities and process improvement work including 5S and problem-solving.
Identify and propose process improvements while maintaining quality and cGMP compliance.
Perform inventory control using SAP.
Documentation & Compliance:
Perform batch record and GMP documentation entries, including mathematical computations; maintain records and logs as required.
Access and print SOPs and forms via ECMS as required.
Use process documents including SOPs, forms, and batch records to guide work; report discrepancies to supervisor.
Follow job-related safety procedures including PPEs, LOTO, ergonomics, material handling, chemical/waste/spill controls, and human safety.
Training & Development:
Acquire and maintain all required certifications and qualifications for the assigned work area, including visual inspection qualification and cold room training.
Cross-train and support other work areas as needed.
Attend and actively participate in daily Tier 1 meetings.
Minimum Qualifications:
Prior experience in a regulated manufacturing environment.
Ability to detect visual defects and perform repetitive inspection tasks with sustained accuracy.
Working knowledge of product security controls and material handling equipment.
Demonstrated documentation and data entry skills, including accurate completion of batch records and logbooks.
Basic mathematical skills, including the ability to perform routine calculations (e.g., weights, measures, conversions).
Ability to effectively read, write, speak, and understand English to interpret SOPs, batch records, and work instructions.
Ability to follow written procedures and work instructions with minimal supervision, escalating issues as needed.
Basic problem-solving skills and the 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.
Prior inspection experience.
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.
Familiarity with defect classification, batch documentation, and GDP/GMP practices.
Working knowledge of Microsoft applications, SAP and/or Veeva Vault.
Experience working in a lean manufacturing 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.
[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.
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 $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. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.