Manufacturing Technician II, Inspection (Nights)
Resilience is a technology-focused biomanufacturing company 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.
About the role
The Manufacturing Technician II reports to a Manager/Supervisor in the Inspection Process Execution Team (PET) operations. This position requires working in various Controlled/Non-Classified areas. The Technician performs manufacturing tasks and supports improvement activities in accordance with cGMPs.
Responsibilities
- Operate assigned machinery, including servicing automated inspection equipment, monitoring equipment status, reintroducing materials, manually palletizing inspected materials, and ensuring smooth product flow.
- Perform manual visual, cosmetic, and physical inspection of material; escalate concerns to Lead and Manager/Supervisor as needed. Maintain visual inspection qualification.
- Start up equipment, make minor adjustments, remove jams, perform minor troubleshooting, and conduct minor assembly/disassembly for cleaning.
- Use material handling equipment such as motorized and manual pallet jacks, and non-motorized lifts.
- Perform cleaning, housekeeping, and line clearance activities to maintain a cGMP environment.
- Complete batch record and GMP documentation entries, including mathematical computations where needed.
- Maintain records and logs related to job responsibilities, including knowledge of product security controls and material handling equipment.
- Ensure outgoing quality level and familiarity with job-related safety procedures (PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls). Report discrepancies to process facilitator.
- Perform work in accordance with SOPs, cGMPs, and OSHA safety procedures; be familiar with Material Safety Data Sheets for area chemicals.
- Print SOPs/Forms via ECMS as required.
- Support lean activities and process improvement, including 5S, problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
- Review process documents (SOPs, forms, batch records) for accuracy and suggest improvements while maintaining quality and cGMP compliance.
- Be flexible and support other work areas as needed.
- Perform other assigned duties with minimal supervision under the direction of the process facilitator or designee.
Optional Training / Responsibilities
- Obtain cold room training/access to transfer materials in and out of cold rooms.
- Complete training to become a certified trainer on assigned equipment and process tasks; train and evaluate other team members.
- Develop novice to intermediate knowledge of SAP inventory movements and management, including moving items between storage locations and goods issuing.
Requirements
- Acquire and maintain all required certifications and qualifications for the assigned work area.
- Capable and motivated to learn new skills and develop capabilities to contribute to the Process Execution Team.
- Ability to work effectively in a team environment and adapt to a changing/demanding environment.
- Some overtime may be required with minimal advance notice to support business needs.
- Experience in a pharmaceutical or cGMP regulated environment.
- Ability to effectively understand, read, write, communicate, and follow instructions in English.
- Strong attention to detail; capable of keeping accurate records and performing mathematical calculations.
Preferred Qualifications
- Prior production experience.
- Experience working in a LEAN manufacturing environment.
- Knowledge of cGMPs and FDA policies/procedures.
- Prior inspection experience in a pharmaceutical manufacturing environment.
Sponsorship or support for work authorization, including visas, is not available for this position.
Pay
Target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay depends on geographical location, relevant experience, qualifications, skills, and knowledge.
Benefits
- Robust total rewards program, including an annual cash bonus program.
- 401(k) plan with a generous company match.
- Comprehensive healthcare (medical, dental, and vision).
- Family-building benefits, life and disability insurance.
- Paid vacation, holidays, and other leaves of absence.
- Tuition reimbursement and support for caregiving needs.