Manufacturing Technician IV, Lead - Parts Prep

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 is a Day Shift (B) - 12-Hour Rotating Schedule**

Position Summary:
This position reports to a Process Execution Team (PET) Supervisor/Manager on the Manufacturing floor, which supports Parts Prep operations. This position will require working in various Controlled/Non-Classified areas. The Parts Prep Lead operates equipment such as parts washers and autoclaves; inspects, cleans, and sterilizes equipment; assembles anddisassembles equipment; performs area cleanings in accordance with the cleaning schedule; and completes batch record entries. Additionally, the Lead Technician will provide training for Technicians and serve as a resource for implementing continuous improvement projects.

Lead and monitor process execution activities to ensure successful operations on the production floor. Typical duties include leading daily Tier 0 meetings, assigning daily tasks to technicians, monitoring material and supply levels, and coordinating production tasks such as batch execution.

* Serve as a primary point of contact for the team. Provide support to production technicians and mechanical technicians. Resolve production-related issues, including batch setup, execution, technical intervention, documentation, equipment operations, line SOPs, and safety and quality inspection procedures. * Perform technician tasks as required, including start-up, equipment operation, batch execution, material handling, cleaning, housekeeping, and line clearance activities.

**This is a Day Shift (B) - 12-Hour Rotating Schedule**

Position Responsibilities:

• Responsible for assembling, disassembling, wrapping, operating, and rinsing/sanitizing various equipment.
• Obtain knowledge to be able to print off SOP's/Forms via EDMS.
• Perform visual inspections of equipment for cleanliness as specified per SOP. Must obtain visual inspection training certification.
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Obtain an intermediate to advanced level of knowledge of SAP inventory movements and inventory management, including goods issuing items to process orders, and utilize advanced functions such as LS24, CO60XT, MB1A, and MB51 for material management anddiscrepancy resolution as required.
• Manage batch records and GMP documentation on the production floor. Review documentation for completeness and accuracy in accordance with GxP standards within established timelines.
• Assist and train others to complete documentation as required. 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 the Area Manager.
• Perform work responsibilities in a responsible manner, in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMPs), and established safety procedures, ensuring compliance with OSHA requirements and guidelines. Be familiar with "Material Safety Data Sheets" for area chemicals.
• Support lean activities, such as implementing 5S in the work area, participating in problem-solving, and conducting process improvement analyses. Lead Level 0 problem-solving on process-related issues and generate One Point Lesson communications as needed.
• Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations of other team members to assess their training qualifications.
• Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties.
• Be flexible in training and support other formulation functions and work areas as needed.
• Assist technical staff as required with preventive maintenance procedures.
• Serve as a project resource to PET, assisting in the timely follow-up and implementation of projects and validation activities.
• Perform all other assigned duties with minimal supervision under the direction of the Area Manager or designee as needed.
• Sterile gowning qualification may be required for sterile core operators. Sterile core operators will also understand aseptic behaviors and media fills, including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment.
• May be required to obtain cold room training and access to transfer materials in and out of the cold rooms.
• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Maintain Aseptic Processing and Gowning certifications as required.
• Some overtime may be required with minimal advance notice to support business needs.

Minimum Qualifications:

• Experience in a pharmaceutical production environment
• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
• Attention to detail is crucial. Individual must be capable of keeping accurate records and performing mathematical calculations.
• 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 continually learn new skills and develop new capabilitiesto contribute to the success of the Process Execution Team.
• The candidate should possess the ability to work in and adapt to a dynamic and demanding environment.

Preferred Qualifications:

• High school graduate, vocational school graduate or equivalent
• Working knowledge of Microsoft applications, SAP, Workday, and Veeva
• Experience working in a LEAN manufacturing environment. Knowledge of cGMPs and FDA policies/procedures
• Basic knowledge of clean room techniques, chemical handling, and usage.
• Possess basic mechanical and technical knowledge and aptitude.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.