Manufacturing Technician II, PFS Inspection (Night Shift)

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

Job Summary

The Manufacturing Technician II, Inspector is a direct labor position reporting to a Process Execution Team (IDAP) Manager on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified areas. The Technician performs a variety of manufacturing tasks (operates equipment, performs visual, cosmetic, and physical inspection, line clearances, operating manufacturing equipment, and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) in accordance with cGMPs.

**Night shift position working 6pm- 6:30am. 2 days on, 2 days off, 3 days on, 3 days off then the rotation starts over again.

Job Responsibilities

• Perform the duties of operating assigned machinery consisting of servicing automated inspection equipment, monitoring equipment status, reintroduction of materials, manually palletizing inspected materials, and assuring a smooth flow of product. Crosstrain on other manufacturing equipment as needed.
• 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.
• Be able to start up equipment, make minor adjustments to machinery, remove jams, minor troubleshooting, and minor assembly/disassembly for cleaning purpose.
• Ability to use material handling equipment such as motorized and manual pallet jacks, non-motorized 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 process facilitator.
• 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.

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 process facilitator or designee as needed.

Competencies & Job Requirements

• 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 Qualifications

• 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.

Preferred Qualifications

• 1 Year of experience in a pharmaceutical or cGMP regulated environment
• Prior production experience
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

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.