What You Will Achieve:

The Lead Validation Engineer is directly responsible for management and execution of all special projects in support of Canton and Norwood facilities.

How You Will Achieve It:

• Special project scope determination, execution scheduling and management, validation plan generation (as needed), IQ, OQ and PQ (as needed) protocol generation, and review and/or approval of protocols and final reports.  Examples of special projects include full autoclave qualification, Centrifuge qualifications, and large-scale revalidations for equipment, systems, and facilities modifications.
• Provide direction to Validation Engineers at the Norwood site as well as directing consultants on special projects.
• Oversight and validation guidance for existing CMO’s. This guidance includes assessment of changes to qualified equipment, systems and processes, and new equipment qualification review and approvals.
• This position reports directly to the Associate Director of Validation.

Requirements

What You Need to Achieve It:

• Bachelor’s degree in a related life science field
• 6-9 years of hands-on experience in managing and leading execution of large-scale validation projects.
• Working knowledge of requirements and execution for qualification of Controlled Temperature Units (CTUs) including the following: refrigerators, walk-in units, freezers, Controlled Rate Freezers.
• Additional competencies shall include autoclave, oven and Isolator qualification and requalification requirements, testing, and execution data review for meeting acceptance criteria.
• Understanding of critical utilities (WFI, PW, CA, CS, etc.) qualification requirements and testing.
• Additional strong working knowledge of Computer System validations is a bonus.

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy - $5,000 per year for all employees
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking including an electric charging station (Canton and La Jolla)
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.