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Process Technician
Exton, PA
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Process Technician in Exton, PA. Under supervision and guidance, the Process Technician of Upstream Operations will be responsible for hand-on executing the routine operation, maintenance, and periodically requalification of cell culture based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Work in a hands-on capacity in the operation of upstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances.
* Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records.
* Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.
* Perform process performance sampling/ in process testing supporting the manufacturing.
* Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting is expected.
* Participate and contribute to the validation maintenance, re-qualification of upstream (cell culture and harvest) production equipment.
* Assist in and contribute to the commissioning of new equipment for upstream manufacturing. Participation in other areas within the facility may be added at the company's discretion.
* Assist in equipment maintenance and calibration with appropriate internal departments.
* Provide cross-functional support for other departments within the pilot plant at the discretion of management.
Specifically, this person will participate and contribute to the success of the cell culture and harvest equipment operation and processes for the manufacture of materials for global clinical supplies. The individual will also participate in monitoring and maintaining the production area processes to remain compliant to regulations. The individual may also supporting a campaign and may provide cross-functional support for other departments within the pilot plant at the discretion of management.
EXPERIENCE
Minimum of 2-4 years ( with Associate degree) or 0-2 years (with BS) of practical scientific experience.
EDUCATION
Two-year Associate degree or Four-year BS in Biotechnology or (Bio)Chemical Engineering or Engineering or Biological Sciences or equivalent job experience/degree is strongly preferred.
To be a best-fit your strengths must include:
* Ability to follow direction, work under supervision, and demonstrate capability in organizing complex activities in a cGMP production process.
* Basic skills in executing routine production, maintenance, and operation of upstream cell culture and harvest equipment. Must have a Mechanical aptitude.
* Good aseptic technique in maintaining process sterility.
* Good written, communication, and interpersonal skills with the ability to work in a team environment required.
* Capabilities in the operation of all area-specific production equipment such as large scale stir tank and/or single-use disposable bioreactors, centrifuge, micro-filtration, and CIP/SIP operations is a plus.
* Previous exposures to cGMP, EMEA, and JP regulations as a plus.
508936
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
We are currently searching for a skilled professional to join a well-known client's team as a Process Technician in Exton, PA. Under supervision and guidance, the Process Technician of Upstream Operations will be responsible for hand-on executing the routine operation, maintenance, and periodically requalification of cell culture based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Work in a hands-on capacity in the operation of upstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances.
* Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records.
* Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.
* Perform process performance sampling/ in process testing supporting the manufacturing.
* Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting is expected.
* Participate and contribute to the validation maintenance, re-qualification of upstream (cell culture and harvest) production equipment.
* Assist in and contribute to the commissioning of new equipment for upstream manufacturing. Participation in other areas within the facility may be added at the company's discretion.
* Assist in equipment maintenance and calibration with appropriate internal departments.
* Provide cross-functional support for other departments within the pilot plant at the discretion of management.
Specifically, this person will participate and contribute to the success of the cell culture and harvest equipment operation and processes for the manufacture of materials for global clinical supplies. The individual will also participate in monitoring and maintaining the production area processes to remain compliant to regulations. The individual may also supporting a campaign and may provide cross-functional support for other departments within the pilot plant at the discretion of management.
EXPERIENCE
Minimum of 2-4 years ( with Associate degree) or 0-2 years (with BS) of practical scientific experience.
EDUCATION
Two-year Associate degree or Four-year BS in Biotechnology or (Bio)Chemical Engineering or Engineering or Biological Sciences or equivalent job experience/degree is strongly preferred.
To be a best-fit your strengths must include:
* Ability to follow direction, work under supervision, and demonstrate capability in organizing complex activities in a cGMP production process.
* Basic skills in executing routine production, maintenance, and operation of upstream cell culture and harvest equipment. Must have a Mechanical aptitude.
* Good aseptic technique in maintaining process sterility.
* Good written, communication, and interpersonal skills with the ability to work in a team environment required.
* Capabilities in the operation of all area-specific production equipment such as large scale stir tank and/or single-use disposable bioreactors, centrifuge, micro-filtration, and CIP/SIP operations is a plus.
* Previous exposures to cGMP, EMEA, and JP regulations as a plus.
508936
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
2 to 4 years
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