Quality Engineer

How You’ll 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 You’ll 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.

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.

The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications),  qualifications, performance, and geographic location, among other relevant business or organizational needs.