Manufacturing Technician IV, Lead

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

The Lead Technician reports to a Manager/Supervisor on the Manufacturing floor, which supports Packaging operations. This position will require working in various Controlled/Non-Classified areas. The Lead Technician 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, the Lead Technician will execute training for Inspection Technicians, conduct batch reconciliation and accountabilities per cGMPs, and perform the role of an Inspection Technician as needed. The Lead Technician will also serve as a resource for the implementation of continuous improvement projects.

Job 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 technician tasks as required including start-up, equipment operation, manual inspection, 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.

• 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 Process Facilitators and Engineers, creating an collaborative environment for all Packaging 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.

• Experience in a pharmaceutical production environment

• Experience working in a LEAN manufacturing environment

• Knowledge of cGMPs and FDA policies/procedures

Preferred Qualifications

• High school graduate, vocational school graduate or equivalent

• Working knowledge of Microsoft applications, SAP and Veeva Vault

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.