Validation Engineer

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Position Overview

The Validation Engineer role will lead validation activities supporting cGMP medical device and research use only reagent manufacturing across multiple Exact Sciences facilities. The Validation Engineer will participate in a variety of validation functions including but not limited to, validation protocol generation, validation execution, summary report generation, as well strategy planning and improvements to validation procedures/processes.

Essential Duties

include but are not limited to the following:

• Supports the introduction of new products or services through validation activities. Provides project leadership within Validation as well as supporting functions.
• Actively contributes to the writing of validation plans/protocols, summary reports and compiling objective evidence.
• Coordinates and executes validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping manager regularly updated. Provides direction on equipment change control in accordance with appropriate procedures.
• Support Metrology during equipment installation, calibration, and qualification activities.
• Author SOPs, protocols, lab procedures, and other quality documentation required for new or pre-existing equipment. Management and coordination of space planning (current and future) for the Manufacturing Sciences Product Support and Technical Transfer teams.
• Reviews and approves validation protocols and summary reports prepared by other team members.
• Provide support in cross functional teams, as required. Lead cross functional discussions for simple troubleshooting (i.e Metrology, Quality Control, Facilities, Engineering, and Quality Engineering)
• Coordinates the development of specifications (i.e., user requirements, functional requirements, and design requirements).
• Participates in Process Failure Mode and Effects Analysis (FMEA) risk assessments.
• Assists operators in understanding and documenting validation execution through training and being present during validation execution activities performed by other groups.
• Exhibits excellent coaching/mentoring skills. Provides real-time feedback and defect awareness to team members, sets example to team members for lab etiquette/behavior, course correcting as needed.
• Develop Validation Associates via operator training/certification programs, acting as a certified trainer.
• Determine timelines and consistently hit deliverables and commitments.
• Delegate, adapt, and demonstrate flexibility. Take calculated risks to exceed expectations. Renegotiate timelines with suggested path forward based business prioritization.
• Function independently with limited guidance from supervisor as well as part of a team. Capable of leading teams to achieve business results. Proactive and forward thinking to plan and shift directions based on priorities/need.
• Strong knowledge base in Molecular Biology, Biochemistry, Biotechnology, Chemistry, or a related field.
• Strong understanding of in-vitro diagnostic product manufacturing processes and relevant assays (e.g. biochemical, RT-PCR, and NGS).
• Excellent verbal and written communication skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Act with an inclusion mindset and model these behaviors for the organization.
• Ability to work nights and/or weekends, as needed.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor's degree in life sciences or a field related to the essential duties of this role.
• 5+ years of experience doing validation in a manufacturing environment or a field related to the essential duties of this role.;
• Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint).
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Experience in Validation principles and practice, including equipment qualification, process validation, test method validation, cleaning validation, and computer system validation.
• Strong knowledge of continuous improvement methodologies/principles.
• Familiarity with Project Management Principles and Practices.
• Experience using Electronic Quality Management System (EQMS) software (Agile preferred).
• Experience in a biotech manufacturing environment, preferably in a GMP and/or ISO 13485 environment.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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