Title: Quality Assurance Validation Engineer II
The Quality Assurance Validation Engineer II is an associate with high level of expertise and experience with general biopharmaceutical manufacturing equipment, principles and processes and has a strong understanding of current GXPs, safety, and regulatory standards. The Quality Assurance Validation Engineer II will work closely with Lead Quality Assurance Validation Engineer and provide support to the Validation, Maintenance, Engineering, Automation, Metrology, Manufacturing Sciences, Lab operations, as well as Quality System teams. collaborates with subject matter experts and technical specialists to provide Quality oversight for operation of a cGMP compliant Manufacturing facility with quality assurance needs as defined by departmental management. The Quality Assurance Validation Engineer II will be responsible for providing QA support in facility, utility, equipment, and construction GxP activities for Brammer Bio/Thermo Fisher sites primarily located at Cambridge and Somerville MA, and as needed Alachua FL. Activities include Review of validation documentation, change control, equipment maintenance, automation, and QA capital projects.
Must have strong knowledge of 21 CFR, ICH, and EU regulations
Must possess strong knowledge of QbD, Risk Based approach, and performing Risk Assessments
Must be skilled in the use of a personal computers and related software applications.
Must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.
Must be able to understand operational documents for GMP compliance, accuracy and completeness.
Knowledge, Skill, and Requirements:
Bachelor’s Degree in Sciences or Education
Minimum of 4-6 years’ industry related experience with a bachelor’s degree
Strong interpersonal and communications skills; written and oral
Solid understanding of applicable regulatory requirements