Engineer, Pharma Validation

Job Description: Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products.Lead the authoring and executing of protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results.Coach and assist Pharma Validation Engineers through the validation process.Responsible for revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations.Plan, communicate and lead scientifically sound qualification/validation strategies for large scale projects.Perform engineering studies to determine if projects are feasible.Suggest OEE Improvements and participate in continuous improvement team.Communicate with functional groups regarding the needs and status of assigned study execution activities.Manage vendors and service providers for validation and installation requirements.Provide coaching and mentoring to Pharma Validation team.Develop and execute cleaning validations and ensure compliance with regulatory requirements.Requirements: Bachelor of Science Degree in Biology, Chemistry or Engineering.At least 4 years of validation experience in a cGMP Device or Drug environment.Experience with validations of USP water, controlled environments or equipment validations in a regulated environment.Experience with validation documentation and related change control.Ability to control and coordinate concurrent projects, competing priorities and critical deadlines.Experience assessing and initiating actions independently.Experience taking charge of a situation, team or project.Ability to build and maintain relationships within and between teams.Strong oral and writing skills.Preferred: Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.Six Sigma certification.Validation experience in a pharmaceutical or Medical Device manufacturing environment.Experience with NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products.Experience with validation of various product types such as liquid products, solid dosage products, and multi-component products.Benefits: Health insuranceLife and disability401(k) contributionsPaid time offEmployee Assistance ProgramEmployee Resource GroupsEmployee Service Corp