- Authors, supports, updates, and/or leads documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation
- Supports deviations, including assessment of product impact and determination of root cause and corrective/preventative actions, assists in writing of investigations as well as quality incidents.
- Supports equipment, and facility projects for the Culture Media and Weigh and Dispense Operations, and Black Widow Spider areas.
- Supports continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
- Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
- Designs, conducts, and/or reviews and approves experimental protocols as needed.
- Provides on-the-floor support of complex operational and technical (process/equipment) issues.
- Completes and/or leads projects to improve the performance of our Company processes, including investigation and execution of Corrective/Preventative Actions (CAPAs); projects aimed at improving Right-First-Time performance or preventing/reducing deviations; and projects that seek to improve efficiency, reduce cost, or increase compliance.
- Supports team safety, environmental, and compliance objectives.
- Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
- Partners effectively with Operations, Quality, Planning, project teams, and external vendors.
- Authors, supports, updates, and/or leads documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation
- Supports deviations, including assessment of product impact and determination of root cause and corrective/preventative actions, assists in writing of investigations as well as quality incidents.
- Supports equipment, and facility projects for the Culture Media and Weigh and Dispense Operations, and Black Widow Spider areas.
- Supports continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
- Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
- Designs, conducts, and/or reviews and approves experimental protocols as needed.
- Provides on-the-floor support of complex operational and technical (process/equipment) issues.
- Completes and/or leads projects to improve the performance of our Company processes, including investigation and execution of Corrective/Preventative Actions (CAPAs); projects aimed at improving Right-First-Time performance or preventing/reducing deviations; and projects that seek to improve efficiency, reduce cost, or increase compliance.
- Supports team safety, environmental, and compliance objectives.
- Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
- Partners effectively with Operations, Quality, Planning, project teams, and external vendors.
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Engineer II - Lansdale, United States - Innova Solutions
Description
Job Description:
Responsibilities:
Qualifications:
Education Requirements:
B.S. or B.A. in Engineering, Sciences, or related discipline. 2-4 yrs experience (combination of co-op/Real world acceptable).
Required Experience and Skills:
Strong Technical Writing Skills, Highly developed communication, leadership and teamwork skills, Ability to manage projects/work to schedule/deadlines
Preferred Experience and Skills:
Experience in biologics, vaccine, or bulk sterile manufacturing facilities, Change Control experience, Deviation Management Investigation.
