Engineering - Assistant Process Engineer - TechDigital
Devens, MA
About the Job
Onsite
Qualifications
Knowledge of process engineering and science generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent.
A minimum of 2 years relevant experience in biopharmaceutical industry or its equivalent.
Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment.
Understanding of process and equipment validation principles
Knowledge of biopharmaceutical facility design and manufacturing operations. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable.
Knowledge of project management principles including proficient use of project management tools and software such as MS Project and other collaborative systems.
Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization.
Job Responsibilities-
1. Supports the technical transfer and scale-up of biological processes from process development into clinical manufacturing.
2. Authors facility fit reports and schedule adherence to each aspects of the tech transfers.
3. Responsible for interacting with cross functional teams to forecast and procure required raw materials.
4. Assists in the implementation of new technologies from Development into Operations.
5. Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements
6. Compiles data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary.
7. Assists in the review and approval for manufacturing batch records.
8. Actively participates in an environment which fosters safety, quality and continuous improvement in cost and customer service.
Qualifications
Knowledge of process engineering and science generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent.
A minimum of 2 years relevant experience in biopharmaceutical industry or its equivalent.
Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment.
Understanding of process and equipment validation principles
Knowledge of biopharmaceutical facility design and manufacturing operations. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable.
Knowledge of project management principles including proficient use of project management tools and software such as MS Project and other collaborative systems.
Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization.
Job Responsibilities-
1. Supports the technical transfer and scale-up of biological processes from process development into clinical manufacturing.
2. Authors facility fit reports and schedule adherence to each aspects of the tech transfers.
3. Responsible for interacting with cross functional teams to forecast and procure required raw materials.
4. Assists in the implementation of new technologies from Development into Operations.
5. Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements
6. Compiles data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary.
7. Assists in the review and approval for manufacturing batch records.
8. Actively participates in an environment which fosters safety, quality and continuous improvement in cost and customer service.
Source : TechDigital