Senior Quality Engineer
Senior Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
At Azenta new ideas new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.
All we accomplish is grounded in our core values of Customer Focus Achievement Accountability Teamwork Employee Value and Integrity
Job Title
Senior Quality EngineerJob Description
How Youll Add Value
The Senior Quality Engineer manages preparation and execution of validation protocols for GxP/regulated processes software laboratory equipment and methods. The position includes writing protocols reports and compiling data and attachments into comprehensive validation packages. Additionally the role is responsible for assisting with the development of requirements procedures specifications validation master plans and other validation related documentation and working successfully with other staff on validation tasks.
What Youll Do
Manage and coordinate:
the preparation review and approval of validation plans.
the preparation review and issuing of validation protocols and reports.
validation documentation including risk assessments traceability matrices and validation reports.
the review and approval of requirements and specifications associated with Equipment Processes and Computerized Systems.
all project validation activities (including vendors).
periodic reviews and user reviews of software solutions
Coordinate and assist in the development and execution of Validation protocols and work closely with staff to lead execution. Provide technical assistance to other departments regarding validation issues. Develop and edit controlled documentation pertaining to validation activities and related systems. Provide audit (internal client regulatory) support regarding validation activities. Participate in CAPA and remediation activities where required. Lead technical and regulatory assessment of new software solutions updates/ new releases to existing systems and new licenses/ accreditations desired by leadership. Maintain working knowledge of regulatory requirements and industry best practices regarding validation
What You Will Bring
- Four-year degree preferred in Life Sciences Computer Science or Engineering.
- 5 years relevant experience in validation. Previous software validation experience is required.
- 3 years experience working in GxP/ regulated environment
Preferred Qualifications
- Experience with validation protocols (IQ/OQ/PQ) for environmental monitoring system or ultra-cold storage.
- Experience with contributing to multiple projects with dynamic deadlines
- Working knowledge of 21CFR Part 11 EU Annex 11 UK MHRA and other data integrity regulations
- Working knowledge of CAP ISPE GAMP and ICH guidelines
- Experience writing technical documents and a high level of Microsoft Word and Excel expertise.
- Strong analytical skills and the ability to think creatively.
- Excellent leadership skills and ability to work across organization.
- Self-directed with a high degree of professional integrity organization and attention to detail.
- Strong communication interpersonal and collaborative skills.
Your Working Conditions:
- Employee will be working in an area with potentially infectious materials. Employee will be responsible for maintaining a clean work environment while enforcing and following universal precautions for blood borne pathogens when working in an area considered to be potentially contaminated.
- Some travel including international travel may be required.
If any applicant is unable to complete an application or respond to a job opening because of a disability please email at for assistance.
Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race color age religion gender sexual orientation gender identity national origin disability or veteran status.
Required Experience:
Senior IC
Employment Type
Full-Time
