Purification Manufacturing Technician I
Contract : 6 Months
Pay Rate : $52.70 / hr
Location- Onsite : Hopewell, NJ
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.
Hours : 40 hours / week
Over-time may be required on occasion
100% ONSITE
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