Validation Specialist

Portsmouth, New Hampshire, United States

Job Summary:The Analytical Validation Specialist III will assist in validation activities, including but not limited to software updates, new system introduction, and decommissioning of analytical systems. The individual will work closely with Senior Analytical Validation Specialists and other functional groups to contribute to quality and right-first-time performance. This role requires close support from other Subject Matter Experts and Management.

Key Responsibilities:

• Assist in validation activities for software updates, new system introductions, and system decommissioning.
• Collaborate with Senior Analytical Validation Specialists and cross-functional teams to ensure quality and efficiency.
• Support the development and execution of validation protocols and reports.
• Conduct risk assessments and ensure compliance with regulatory requirements.
• Troubleshoot and resolve validation issues in a timely manner.
• Maintain accurate documentation of validation activities.
• Provide training and support to junior team members and other departments as needed.

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, or related field.
• Minimum of 5 years of experience in analytical validation or related field.
• Strong understanding of validation principles and regulatory requirements.
• Excellent analytical and problem-solving skills.
• Strong attention to detail and ability to work independently and as part of a team.
• Effective communication and interpersonal skills.

Preferred Qualifications:

• Master's degree in Chemistry, Biochemistry, or related field.
• Experience with validation of analytical systems in a regulated environment.
• Knowledge of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).