Validation Specialist II

Responsibilities:
*Support the Product and Process Validation effort by analyzing and compiling data and test results.
*Provide documented evidence that manufacturing equipment consistently produces results that meet specifications and quality attributes.
*Design validation protocols that incorporate process variables, sampling methods and acceptance criteria.
*Gather information needed to design the protocols by interacting with Pharmaceutical Research and Development, Document Control, Operations and Drug Regulatory Affairs.
*Summarize validation results in well-organized, accurate and complete validation documentation formats in support of cGMP and FDA compliance.
*Track and coordinate project assignments.
REQUIREMENTS
Minimum Qualifications:
*BS in life sciences, engineering or equivalent expertise.
*Must have 3-5 years experience in pharmaceutical validations environment.
*Candidate should have exposure to the following software groupsL LIMBS, SEVEN I, MES, SIMS. Specific experience with Boundry testing, ladder logic & Input/output testing a plus.
*Advanced knowledge in math and statistics.
*Must have excellent technical writing skills.
*Proficient in word processing/spreadsheet programs.
*Knowledge of cGMP regulations.
*Ability to work with little supervision, interpersonal interaction skills, attention to detail & ability to set changing priorities is key.

Certifications Preferred:
Certified Quality Engineer (CQE), professional certification or equivalent expertise.