Manufacturing Technician II, Formulation (Night Shift) at Resilience

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 Manufacturing Technician II reports to a Process Execution Team Manufacture Supervisor on the Manufacturing floor, which supports Formulation operations. The position requires operating equipment in various controlled/non-classified and classified areas, product sampling, line clearances, data collection and completing batch record entries. In addition, the Technician will perform setup of equipment, direct product sampling activities and perform batch reconciliation and accountabilities per cGMPs. The Technician will also serve as a resource for the implementation of continuous improvement projects.

Job Responsibilities

• Monitor process execution activities to ensure successful operations on the production floor. Typical duties include attending daily Tier 0 meetings, monitoring material and supply levels, and coordinating production tasks such as batch execution.
• Work collaboratively with mechanic technicians and lead technicians to resolve production-related issues such as batch set-up, execution, documentation, equipment operations, SOPs, and safety and quality inspection procedures.
• Perform clean in place and steam in place of process lines per SOPs.
• Perform, set up, and create single use connections including single use bags.
• Perform and execute filter integrity testing as needed per SOP.
• Perform parts washing of parts as necessary.
• Perform dispensing operations as necessary.
• Perform inventory control, which will require the use of SAP.
• Responsible for start-up, equipment operation, batch execution, material handling, cleaning, housekeeping and line clearance activities
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Perform batch record and GMP documentation entries. Assist others to complete documentation as required. This will include mathematical computation where needed.
• Knowledge of light material handling equipment.
• Working knowledge of automated and semi-automated equipment (pumps, mixers, etc).
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines.
• Support lean activities such as performing 5S in the work area, participating in problem-solving, and process improvement analysis.
• Responsible for assembling, disassembling, and sanitizing various equipment.
• Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties.
• Be flexible in cross training and support other work areas as needed.
• Assist technical staff as required with preventive maintenance procedures
• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.

Minimum Requirements

• 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
• Acquire and maintain all required certifications and qualifications for the assigned work area
• Good organizational skills, situational leadership, and decision-making skills
• 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

Preferred Background

• Working knowledge of Microsoft applications, SAP and Veeva Vault
• High school graduate, vocational school graduate or equivalent
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures
• Experience in a pharmaceutical production environment
• Basic knowledge of clean room techniques, chemical handling and usage

This position may also include the following:

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion,

temperature changes, and exerting up to 100 pounds of force to move objects.

• Visual acuity (such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.)
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Exposure to the following:

• Moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals.
• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Close quarters, narrow passageways, crawl spaces, shafts, manholes, small enclosed rooms, small sewage and line pipes.
• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
• Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).

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.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $21.50 - $30.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.