Quality Validation Associate

The Validation Specialist supports preparation and execution of validation protocols for GxP/regulated processes, software, and 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 Brooks Life Sciences/GENEWIZ staff on validation tasks.

This position can be located at either our Indianapolis, IN, South Plainfield, NJ location or Remote.

Job Responsibilities:

- Manage and coordinate:

the preparation, review, and approval of Validation Master 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).

- 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.

- Participate in CAPA, periodic review and remediation activities where required.

- Assist in technical and regulatory assessment of new software solutions or updates and new releases to existing systems.

Qualifications:

• Two-year degree, preferred in Life Sciences, Computer Science or Engineering. 

• 3+ years relevant experience in validation.  Previous software validation experience is required.

Preferred Qualifications:

• Four-year degree

• Experience in the Life Sciences industry or other highly regulated industry

Key Skills and Position Competencies:

• Working knowledge of 21CFR Part 11 regulation

• 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.

Employee will be working in a facility with potentially infectious materials. Employee will be responsible for maintaining a clean work environment and enforce and follow universal precautions for bloodborne pathogens when working in an area considered to be potentially contaminated.

Travel, including international travel, may be required.