Process Technician - Upstream operations

LanceSoft Inc; Exton (PA); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical staffing firm is seeking a Process Technician for upstream operations. The ideal candidate will have a strong background in operating and maintaining cell-culture based production equipment in a cGMP environment. Responsibilities include executing routine operations, maintaining compliance with regulations, and participating in validation efforts. A minimum of a two-year associate degree or four-year BS in a relevant field is preferred. Strong communication skills and a mechanical aptitude are essential for success in this role.

Qualifications

• Minimum of 2-4 years of practical scientific experience or 0-2 years with a BS degree.
• Must have mechanical aptitude and good aseptic technique.
• Good written and verbal communication skills required.

Responsibilities

• Operate upstream equipment for the manufacture of biologics drug substances.
• Maintain accurate training and cGMP records.
• Perform process performance sampling and in-process testing.

Skills

Follow direction

Organizing complex activities

Basic skills in production and maintenance

Good aseptic technique

Communication and interpersonal skills

Education

Two-year Associate degree

Four-year BS in Biotechnology or equivalent

Tools

Large scale stir tank

Single-use disposable bioreactors

Centrifuge

Micro-filtration

CIP/SIP operations

Job description

Process Technician - Upstream operations

• Contract


• LanceSoft - Pharmaceutical Client

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. In addition, the individual will execute and participate in the execution activities for scale-up and system operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances, including operation of cell-culture bioreactors and harvest equipment, GMP documentation, and ensuring compliance to relevant regulations.

Responsibilities Percent of Time

• Work in a hands-on capacity in the operation of upstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances. (25%)


• Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records. (20%)


• Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices. (20%)


• Perform process performance sampling/in process testing supporting the manufacturing. (20%)


• Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting is expected. (5%)


• Participate and contribute in the validation maintenance, re-qualification of upstream (cell culture and harvest) production equipment. Assist and contribute in the commissioning of new equipment for upstream manufacturing. Participation in other areas within the facility may be added at the company’s discretion. (5%)


• 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. (5%)


• The individual will play a hands-on execution role in the routine operation of the Biological pilot plant whose purpose is to produce material for preclinical, clinical, and commercial biologics drug substance to support Company’s pipelines. Execution of manufacturing in the GMP production suites including documenting data compliantly.


• 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 support 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 year (Associate degree) or 0-2 year (BS) practical scientific experience.


• 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.

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.

All your information will be kept confidential according to EEO guidelines.