Manufacturing Technician IV, Lead - Device Assembly (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

NOTE: Shift: 12hr Nights (6pm - 630am), Schedule: 2-2-3 rotation,

Position Summary

The Manufacturing Technician IV, reports to a Manager/Supervisor on the Manufacturing floor, which supports PET operations. This position will require working in various Controlled/Non- Classified areas. Leads the execution of batch activities on the manufacturing floor, which includes leading daily Tier 1 meetings, assigning daily tasks to production technicians, managing batch documentation, and coordinating production tasks and turnover activities. In addition, will execute training for Technicians, conduct batch reconciliation and accountabilities per cGMPs, and perform the role of a Technician as needed. Will also serve as a resource for the implementation of continuous improvement projects.

Primary Responsibilities
* Lead and monitor process execution activities to ensure successful operations on the production
floor. Typical duties include leading daily Tier 1 meetings, assigning daily tasks to production
technicians, monitoring material and supply levels, and coordinating production tasks such as batch
execution and turnover activities.
* Act as a first-line resource for the team. Provide support to production technicians and mechanic
technicians. Resolve production-related issues such as batch set-up, execution, technical
intervention, documentation, equipment operations, line SOPs, and safety and quality inspection
procedures.
* Perform inventory control and reconciliation activities, which will require the use of SAP and WES
in a limited role.
* Perform technician tasks as required including start-up, equipment operation,
batch execution, material handling, rework, quality inspection, cleaning, housekeeping and line
clearance activities.
* Manage batch records and GMP documentation on the production floor. Review documentation
for completeness and accuracy per GxP standards within established timelines. Assist and train
others to complete documentation as required.
Effective

* Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO,
human safety, material handling, chemical handling, and spill controls.
* Ensure work requirements are followed on the production floor, in accordance with SOPs and
established safety and quality procedures.
* Work alongside Supervisors/Managers and Engineers, creating a collaborative environment for all associates.

Other Responsibilities
* Support lean activities such as performing 5S in the work area, participating in problem-solving,
and manual tracking of performance data for OEE and process improvement analysis. Lead Level
0 problem-solving on process related issues and generate OPL communications as needed.
* Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and
conduct evaluations on other team members for training qualifications.
* 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.
* Execute protocols as required as a part of equipment qualification and process validation work.
* Be flexible and support other work areas within the Team 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.
* Good organizational skills, basic first-line management skills for daily operation, situational
leadership, and decision-making skills
* Ability to work effectively in a team environment.
* Capable and motivated to learn new skills and develop new capabilities on an on-going basis to
contribute to the success of the Team.
* Candidate should possess the ability to work in and adapt 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.
* Good attention to detail is required. Individual must be capable of keeping accurate records and
performing mathematical calculations.

Preferred Qualifications

* Experience in a pharmaceutical production environment
* High school graduate, vocational school graduate or equivalent
* Working knowledge of Microsoft applications, SAP and Veeva Vault
* 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.