Find & Apply For Validation Engineer Jobs in Bedford, New Hampshire

Education:

Validation Strategy and Leadership:

The Quality Assurance (QAV) Validation Specialist Level III will oversee and lead complex QAV validation projects, ensuring that all QAV validation activities meet stringent regulatory and industry standards. This role involves strategic planning, review, approval and continuous improvement of QAV validation processes. The QAV specialist will work closely with senior management and cross-functional teams to drive quality initiatives and mentor junior team members.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are included in the following but other duties may be assigned.

Key Responsibilities:

Develop and implement comprehensive QAV validation strategies for equipment, processes, and computer systems. Lead large-scale QAV validation projects and coordinate cross-functional teams to ensure project milestones are met. Provide technical expertise and guidance on complex validation issues and problem-solving.

Compliance and Risk Management:

Ensure all validation activities comply with regulatory requirements (e.g., FDA, EMA, Annex 11, GAMP 5, 21 CFR Part 11, ISO) and internal quality standards. Conduct risk assessments, impact analyses, and implement mitigation strategies. Stay current with regulatory changes and industry trends to ensure ongoing compliance.

Quality Assurance Validation Oversight:

Review and approve validation protocols, reports, and quality documentation. Lead internal and external audits, inspections, and regulatory reviews. Ensure the robustness and reliability of validation processes through continuous monitoring and improvement.

Continuous Improvement and Innovation:

Identify and implement innovative approaches to enhance validation processes and methodologies. Lead initiatives for process optimization, efficiency improvements, and cost reduction. Drive the development and implementation of validation best practices across the organization.

Mentorship and Training:

Mentor and train junior QAV team members and validation specialists. Develop and deliver training programs on validation processes, regulatory requirements, and quality standards. Foster a culture of quality and continuous improvement within the QAV team.

Documentation and Reporting:

Prepare and review comprehensive validation documentation, including protocols, reports, and summaries. Maintain accurate, organized, and up-to-date validation records. Communicate validation findings, trends, and recommendations to senior management and stakeholders.

Data Integrity:

Ensure data integrity and compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).

Special Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions. Ability to sit for extended periods while reviewing documentation. Ability to stand and walk within manufacturing and laboratory areas. Must be able to wear required PPE in GMP environments. Ability to lift up to 15 pounds occasionally. Ability to work at a computer for extended periods. Must be able to access manufacturing areas and equipment platforms as required.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. This position operates in a combination of office and GMP-regulated manufacturing environments. The employee will work in a professional office setting utilizing standard office equipment (computer, telephone, copier, etc.) and will also regularly attend meetings. Office, manufacturing, and laboratory environment. May require occasional travel to manufacturing sites and other locations.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's degree in a related field (e.g., Biology, Chemistry, Engineering, or a related scientific discipline). Advanced degrees (e.g., Master's, or Ph.D.) preferred.

Skills:

Expert understanding of QAV principles, validation processes, and regulatory requirements. Strong leadership and project management skills. Excellent analytical, problem-solving, and decision-making abilities. Exceptional written and verbal communication skills. Proficiency in relevant software and tools (e.g., Microsoft Office Suite, statistical analysis software).

Experience:

Minimum of > 5 years of experience in QAV validation within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). Proven track record of leading and managing complex validation projects. Extensive experience with regulatory inspections, audits, and compliance.

Working Conditions:

Office, manufacturing, and laboratory environment. May require occasional travel to manufacturing sites and other locations.

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Referral program Tuition reimbursement Vision insurance

Work Location:

In person