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Salary100% Onsite in Lexington, MA
Direct Hire
Salary range: $120K - $125K
****Please note, at least 6 years' of Commissioning, Quality and Validation experience is required for this role along with a Bachelor s degree in Life Sciences or Engineering. A solid understanding of cGMP is needed as well.
****NO THIRD PARTIES
Other experience necessary for the role:
- Qualification of equipment, environmental qualification, process transfer and scale-up, process validation and preparation of cGMP materials and all relevant documentation to meet regulatory requirements of new and existing products (SOPs, technical reports and risk assessments).
- Balance workload of and motivate direct reports and/or contract staff to accomplish department goals and objectives
- Manage protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
- Review and approve qualification documentation on behalf of the validation
- Ensure performance of all qualification activities is in accordance with local procedures, industry and regulatory guidance.
- Support investigations into protocol nonconformances and site
- Serve as initiator and owner of validation related change controls and corrective and preventative actions.
- Author standard operating procedures related to validation
- Support the execution and generation of formal risk
- Support the generation and implementation of validation
- Experience in supervising contract personnel
EDUCATION:
Bachelor s in Life Sciences or Engineering
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
