SEC Associates, Inc., a recognized leader in computer validation and regulatory compliance
consulting for the pharmaceutical, biotechnology and medical device industries has an immediate
opening for a Senior Validation Consultant in the Cambridge, MA area.  SEC offers practical
computer compliance services in the IT, laboratory, clinical trial, and manufacturing domains. 
Our corporate office is located in Research Triangle Park, NC with satellite locations in NJ,
TX and Cambridge, MA.

 

Responsibilities include: Create functional requirements specifications, system design
specifications, validation master plans, test protocols, validation summary reports, and
standard operating procedures in support of both large and small-scale computer systems.  This
includes being able to facilitate requirements gathering sessions and develop validation
documentation either independently or as part of a team; develop Validation Master Plans for
strategic systems or strategic compliance areas; perform and document gap assessments (i.e.,
identify technical and procedural gaps of systems against redefined requirements);  provide
resultant technical and procedural remediation assistance as requested and as permitted by
applicable laws and regulations; comply with GxPs while creating and executing validation
documentation.   This includes understanding regulatory requirements as well as adhering to
good documentation practices.  Must be self-motivated and possess demonstrated project
management skills (including budget, deliverables, schedule, etc.).

Minimum education and experience required: Bachelors degree (advanced degree a plus) in
Information Technology, Engineering or other applicable scientific and technical degrees with 5
years of relevant experience in FDA regulated industry; strong computer skills including MS
Word and Excel; superior written and verbal communication skills.  Some travel is anticipated.

 

SEC provides an atmosphere of individual respect and responsibility, coupled with a platform
for personal and professional growth.  This combination has enabled us to attract and retain
outstanding people that truly make SEC a great place to build a career.  SEC offers a
professional and comfortable work environment with excellent salary and benefits (medical,
profit sharing 401k plan, disability, generous vacation package, paid holidays, performance
bonus plan, etc.).