Purification Manufacturing Technician

1 week ago


Pennington, United States randstad life Full time

Title: Purification Manufacturing Technician I

Duration: 6 Months

Pay Rate: $52/hr

Location- Onsite: Hopewell, NJ 08534


General Description:

The Purification Manufacturing Technician I / II position will directly enable the initial

start-up phase of the Hopewell manufacturing facility and then shift focus to

hands-on execution and support of cGMP manufacturing operations.


1) Facility Start-Up: Focused on cell culture related activities required to design, build,

commission, and license first biopharmaceutical plant in the United States.

Essential functions of the job include but not limited to:

A. Design review

B. Equipment selection, procurement and testing

C. Protocol development and execution

D. Acceptance testing and equipment/automation debugging

E. Technical training


2) Hands-On cGMP Operations: Focused on execution of cGMP manufacturing

activities required to deliver the production plan reliably and compliantly.

Essential functions of the job include but not limited to:

A)Follow cGMP procedures to support manufacturing execution and automated recipes.

B)Clean-In-Place (CIP) & Steam-In-Place (SIP).

C)Buffer preparation & transfers / filtration

D)Operational and cleaning of chromatography and filtration systems.

E)Equipment & process troubleshooting.

F)Deviation identification, reporting and closure.

G) cGMP procedure development and optimization.


Additional Skills/Attributes Required:

? Evidence of good verbal and written communication.

? Ability to work in fast paced dynamic environment with competing priorities.

? Demonstrated ability to collaborate within and between diverse groups.

? Proactive identification and implementation of continuous improvement opportunities.

? Able to receive and incorporate feedback – passion for ongoing professional development a plus.

? Aptitude for learning moderately complex technical systems.


Physical Requirements:

? Must be able to stand for long periods, up to 8 to 12 hours/day.

? Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

? Must be able to work scheduled 40 hours with the ability to work overtime as needed.

? Must be comfortable in working in varying temperatures.

? Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs.

? Regular reaching, bending, stooping, and twisting.

? Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

? Environment requires dedicated gowns, depending on area.

? Work with hazardous materials and chemicals.

? Willing to work any shift.


Required

DESIGN REVIEW

CGMP

CIP/SIP

HAZARDOUS MATERIALS


Education Required:

High school education or GED required - OR - AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.



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