Manufacturing Technician II - Formulation

Resilience•West Chester, OH

3d•$22 - $32

About The Position

Resilience is a technology-focused biomanufacturing company building a sustainable network of end-to-end manufacturing solutions. The Manufacturing Technician II reports to a Supervisor/Manager, Manufacturing and supports Formulation operations. The role operates equipment, performs in-process monitoring and line clearances, collects OEE data, and completes batch record entries in accordance with cGMPs. The position works in a regulated, fast-paced production environment and requires adherence to applicable safety, quality, and compliance procedures. The role is primarily non-sedentary and may include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. Employees use required personal protective equipment and participate in an occupational health program. The expected work schedule may be modified by the Company, including requests for overtime, based on business needs.

Requirements

Prior experience in a regulated manufacturing environment.
Working knowledge of automated and semi-automated equipment, such as pumps and mixers, and light material handling equipment.
Ability to read, write, speak, and understand English to follow detailed instructions and communicate with team members.
Demonstrated attention to detail and ability to accurately complete batch records, logbooks, and other controlled documentation.
Basic problem-solving and mathematical skills, including routine calculations involving weights, measures, and conversions.
Ability to follow SOPs, written procedures, and work instructions with minimal supervision and escalate issues as needed.
Ability to identify process or documentation deviations and inconsistencies.
Ability to work effectively as part of a team in a fast-paced production environment.
Ability to pass an eye exam during onboarding.
Ability to meet the physical demands of the primarily non-sedentary role, including exerting up to 100 pounds of force to move objects.

Nice To Haves

High school graduate, vocational school graduate, or equivalent.
At least 1 year of experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing.
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.

Responsibilities

Perform start-up, equipment operation, batch execution, material handling, cleaning, housekeeping, and line clearance activities to maintain a cGMP environment.
Collaborate with mechanic technicians and lead technicians to resolve production-related issues involving batch setup and execution, documentation, equipment, SOPs, safety, and quality inspection procedures.
Monitor process execution, materials, and supply levels and coordinate production tasks such as batch execution.
Perform clean-in-place and steam-in-place procedures on process lines according to SOPs.
Set up and create single-use connections, including single-use bags.
Perform and execute filter integrity testing as needed according to SOPs.
Perform parts washing and dispensing operations as necessary.
Assemble, disassemble, and sanitize equipment.
Operate automated and semi-automated equipment, including pumps and mixers.
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.
Perform inventory control using SAP.
Complete batch record and GMP documentation entries, including mathematical computations.
Follow safety procedures and use applicable PPE, including procedures for LOTO, ergonomics, material handling, chemical, waste and spill controls, and human safety.
Perform work in accordance with SOPs, cGMPs, established safety procedures, and OSHA requirements and guidelines; report discrepancies to process facilitators.
Acquire and maintain 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.
Adhere to the Quality Management System, including the Quality Manual, Quality Policy, SOPs, cGMPs, and other applicable regulations and standards.