Specialist, Biomanufacturing - Alachua, United States - Resilience

Resilience

Verified Company

Alachua, United States

4 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 & Responsibilities

This position will assist in production-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).

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 equipment
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 onsite 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 Managers
Night shift (7pm7am) Sunday-Tuesday with alternating Wednesday

Minimum Job Qualifications

Experience in a manufacturing environment
Ability to document work clearly and accurately and be detail oriented
Intermediate to advanced computer skills and be proficient with Word and Excel.
Selfmotivated and hard working
English reading comprehension and legible writing skills
Communication and organization skills in a teamwork environment

Preferred Job Qualifications

Possess a B.S. (Biology, Microbiology, Chemistry or equivalent) and work at least 2 years experience in a manufacturing environment
Previous work experience in GMP environment
Experience working as a team member with shared responsibilities

Role/Site Specific Requirements

This role is primarily nonsedentary. 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, 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 nonhazardous waste (which can include: chemicals, universal and ewastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
Working in BSL2/3 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.