Specialist II, Manufacturing (Night Shift - 12-Hour Shifts)

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

Position Summary

This position will assist in production related activities such as room cleaning, buffer/media preparation, upstream, downstream, drug product and manufacturing-related activities in the cGMP Manufacturing Core according to established procedures at the Advanced Development and Manufacturing Facility in Alachua (Florida) and accompanying Area G Manufacturing Facility.

**This is a Night Shift position - 12-hour shifts**
Shift Schedule:

- Wed/Thur/Fri/Sat

- Thur/Fri/Sat

Responsibilities

• Act as a subject matter expert in Upstream or Downstream related activities potentially including adherent and suspension cell culture at small and large scale, cell transfection, media and buffer preparation, bioreactor and fermenter-based production, depth filtration, chromatography purification, centrifugation, and ultracentrifugation, 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.

• Generate and review GMP production related documentation such as Production Batch Records, label templates, Standard Operation Procedures, Change Controls, Deviations, CAPAs, etc.

• Prepare training material and train team members, colleagues, etc.

• Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment

• Works with subject matter experts to trouble-shoot and/or optimize processes as required

• Supports the technical transfer of new products into the manufacturing area

• Properly 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.

• Thorough understanding of operations in vaccine and/or biologics manufacturing and aseptic techniques.

• Adhere to safe working practices.

• Provide other assistance as needed to the Manufacturing Supervisors, and Managers

• Supports other cross-functional teams as necessary to achieve Manufacturing team goals

*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 Qualifications:

• Experience working in a cGMP environment within a pharmaceuticals/biotechnology organization

• Self-motivated and hard working

• English 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-oriented.

Preferred Qualifications:

• A post-secondary degree from an accredited institution with a major field of study in Biology, Chemistry, Engineering or similar may substitute for the required experience (for example, an A.S and 6 years of experience, B.S. and 4 years of experience, M.S. and 2 years of experience).

• 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.

• Communication and organization skills in a teamwork environment.

• Experience working as a manufacturing operator in biologics or vaccine manufacturing operations.

• Experience with regulated systems to perform job duties (i.e. SAP/MES, QAD, Veeva, QMTS, LMS, LIMS, Maximo/Procal, Trackwise, etc.)

• 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.

• Participation in an occupational health program (which requires to participate in medical assessment, surveillance, vaccination, and testing, 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.