| Company: | Oregon Bioscience Association
Portland, OR |
| Job Location: |
Hillsboro, OR (Washington County) |
| Employment Type: | Full Time |
| Department: | Genentech |
Description: |
Under the direction of the Technical Operations Manager, an Engineer II will be accountable for the start-up and on-going support of the Hillsboro, Oregon fill / finish operations, while in full compliance with current Good Manufacturing Practices and Genentech quality and safety policies and standards. In addition to managing the responsibilities below, the successful candidate will need to demonstrate the following traits:
* Able to collaborate with both plant and corporate organizations seamlessly.
* Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity.
* Is able to provide the leadership necessary to maintain a high performance culture. |
Duties: |
Responsibilities:
* Responsible for providing process support which includes knowledge of equipment and process operations, protein and product characteristics, as well as critical quality attributes. Types of equipment including large scale bulk freeze / thaw tanks, component prep, filling, isolators, lyophilizers, automated inspection, CIP/SIP, parts washers, etc.
* Responsible for the tech transfers of new products to the facility including process fit evaluations, determination of in-process testing, etc
* As part of the transfer, collaborate with the corporate Process Research & Development organization to modify existing processes, as required, to complete a successful process fit & transfer to Hillsboro.
* Maximizing equipment/labor efficiency, utilization, cost effectiveness - while meeting required safety and quality levels.
*Participate in the development of fill / finish area SOP's and manufacturing documents as appropriate. Participate in the development of technical fill / finish area training programs for fill / finish mechanics.
* Ensure lessons learned or best practices (internal and external) are shared across the organization and leveraged in facility operation. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
* Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production. |
Qualifications: |
Requirements:
* B.S./M.S. degree in Engineering
* Possess 4-7 years of experience designing, starting-up, and/or operating fill / finish equipment in a regulated environment (i.e. pharma, food, beverage, etc.)
* Experience in the pharma/biotech industry is a plus
* Working knowledge of fill / finish equipment operations & support in a regulated environment
* Demonstrated project management skills
* Ability to work with internal teams, partners, suppliers and customers
* Professional level written and oral communication skills
* Up to 20% Travel will be required to support equipment procurement and factory acceptance testing, as well as tech transfers. |
