QA Validation Engineer

Job Description

Your main responsibilities as an Engineer, QA Validation:

· Review and approve user requirement specifications, automation functional requirement specifications and software design documentation for automated facility, utility and equipment.

· Review and approve FAT’s, SAT’s, Commissioning and Automation Acceptance Testing, qualification (IQ, OQ & PQ) protocols, validation discrepancy reports and final report packages of Facilities, Utilities and Equipment to support implementation of new systems, changes, revalidation and periodic review of existing systems.

· Experience with implementation of data integrity in a GMP environment.

· Define and document the data life cycle for GMP systems.

· Perform Data Integrity Risk Assessment and develop mitigation strategies to address risks.

What we are looking for in an Engineer, QA Validation:

· BS in a technical discipline (Engineering, physical or biological sciences)/Equivalent experience may be considered.

· Training in project management is preferred.

· 5+ years’ experience in a GMP regulated environment (Biotech or equivalent), with

· exhibited knowledge or proficiency in engineering.

· Experience in the review and approval of Validation and Qualification lifecycle documentation such as URS, IQ/OQ/PQ, Commissioning and Automation testing documentation.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

Medical insurance – PPO, HMO & HSA

Dental & Vision insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Expense reimbursement

Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Company Description

R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.

The cornerstone of our success: a knowledgeable and experienced recruiting team.

Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

Full-time

Hybrid remote