Manufacturing Technician III, Inspection Mechanic (nights)

Resilience•West Chester, OH

1d•$24 - $38•Onsite

About The Position

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. This position reports to a Manager/Supervisor on the Inspection team. This position will require working in various Controlled/Non-Classified areas. The Technician performs a variety of manufacturing tasks (operates equipment, performs preventive maintenance, performs minor repairs, performs visual, cosmetic, and physical inspection, line clearances, OEE data collection and completes batch record entries) and support improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) in accordance with cGMP's.

Requirements

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.
Experience in industrial maintenance.

Nice To Haves

Significant experience in a pharmaceutical or cGMP regulated environment
Experience documenting work in a CMMS (Computerized Maintenance Management System).
High school graduate, vocational school graduate or equivalent
Prior production experience
Experience working in a LEAN manufacturing environment
Knowledge of cGMPs and FDA policies/procedures

Responsibilities

Perform the duties of operating assigned machinery consisting of servicing automated inspection equipment, labellers, monitoring equipment status, reintroduction of materials, manually palletizing inspected materials, and assuring a smooth flow of product
Perform preventive maintenance on Manual Inspection booths and AVI equipment where applicable.
Perform manual visual, cosmetic, and physical inspection of material. Promptly escalate concerns to Lead and Manager/Supervisor as needed
Must obtain and maintain visual inspection qualification
Act as a first-line technical resource for the team
Be able to start up equipment, make minor adjustments to machinery, remove jams, minor troubleshooting, and minor assembly/disassembly for cleaning purposes.
Ability to use material handling equipment such as motorized and manual pallet jacks, nonmotorized lifts
Perform cleaning, housekeeping and line clearance activities for assigned areas as required to maintain a cGMP environment.
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
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 Manager/Supervisor
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
Obtain knowledge to be able to print off SOP’s/Forms via ECMS
Obtain a novice to intermediate level of knowledge of SAP inventory movements and inventory management such as moving items from one storage location to another and goods issuing items to process orders as required
Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis
Review process documents such as operational SOPs, forms, and batch records for accuracy
Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise
Be flexible and support other work areas as needed
Perform all other assigned duties with minimal supervision under the direction of the Supervisor/Manager or designee as needed
Obtain cold room training/access to be able to transfer materials in and out of the cold rooms
Take proper training to become certified trainer on assigned equipment and process tasks
Train and conduct evaluations on other team members for training qualifications
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