Manufacturing Associate IV (FT) 24982

Headhunters, LLC's client is seeking a Manufacturing Associate IV position reports to Supervisor/Manager Manufacturing Operations. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites.

II: Responsibilities

-Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment

-Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures

Informs Supervisor on progress of projects, transfer of data, process details, etc.

-Executes batch records according to GMP and site quality standards

-Generates Batch Records, SOPs and Protocols as required

-Responds to off-hour alarms as assigned by the Manager Manufacturing

-Executes manufacturing cleanroom changeover and activation

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

Supports Emergent QA during audits and regulatory inspections

-Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals

Education, Experience & Skills

-High School diploma required, BS preferred

-Minimum 4 years of GMP pharmaceutical experience

-Hands-on experience with the installation, operation, cleaning and maintenance of pharmaceutical GMP equipment

-Computer literate (Word, Excel and PowerPoint)

Physical/Mental Requirements

-Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 10 lbs, and pull 10 lbs.

-Use phone, fax, copier, and computer. Use hand tools and operate fork lift.

-Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Drive automatic/standard vehicle.

-Work outdoors, around noise above conversation level, in hot/cold temperatures, in high humidity, where ventilation is needed, in multiple locations, with restricted access to laboratory, in contact with Select Agents, and with exposure to animals, animal areas, or equipment used in animal areas.

Please email your resume and cover letter to Meredith: Meredith@headhuntersllc.org