Manufacturing Technician III, Inspection Mechanic (nights)

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

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.

Primary 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
 

Other Responsibilities

• 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

Minimum 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.

Preferred Background

• 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

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 $24.00 - $38.00 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.