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Specialist II, Manufacturing

3 months ago

Florida, United States Resilience Full time

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

Position Summary

This position will assist in tech transfer and production of downstream manufacturing-related activities in the cGMP Manufacturing Core according to established procedures at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida).

ResponsibilitiesAct as a subject matter expert Downstream related activities potentially including media and buffer preparation, bioreactor and fermenter-based production, depth filtration, chromatography purification, ultrafiltration/ diafiltration, and viral clearance.Work with Tech Transfer and Technical Operations groups for efficient process design and transfer into the cGMP compliant process suites.Draft Standard Operation Procedures, Work Instructions, Change Controls, and Deviations, and other controlled documentation.Interface with Validation and Calibration engineering teams for startup, testing, and operation of Manufacturing equipmentProperly disinfect and stage materials and equipment into production rooms before the production campaigns.Order equipment and perform installation, qualification, and routine maintenance. Interfaces, schedules, and performs on-site monitoring of outside services of all Manufacturing equipment.Draft and collaborate on Production batch records and review executed records.Write raw material specifications. research, source, and order material and lab wares.Lead activities to support production campaign such as preparation of tubing assemblies, autoclaving, material request, and material transfer into production rooms.Adhere to safe working practices.Provide other assistance as needed to the Manufacturing Supervisors, and ManagersNight shift is 7p-7am working Thursday, Friday, Saturday and ever other Wednesday *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 Minimum QualificationsSelf-motivated and hard workingEnglish reading comprehension and legible writing skills.Must have intermediate to advanced computer skills and be proficient with Word and Excel.Ability to document work clearly and accurately and be detail orientedPreferred Qualifications Possess a B.S. (Biology, Microbiology, Chemistry or equivalent) and minimum 2 years of manufacturing experience or High School diploma, GED, or A.S. degree and +6 years of relevant work experience may substitute.Must have intermediate to advanced computer skills and be proficient with Word and Excel.Experience working as a team member with shared responsibilities is desired.Previous work experience in GMP environment is preferred.Communication and organization skills in a teamwork environment.Experience working as a team member with shared responsibilities is desired.Role/Site Specific Requirements 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 terminals, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.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). The items described here are representative of those that must be met to successfully 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. 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 $ $43.00 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.