Validation Specialist

PharmEng Technology; Portsmouth (NH); On-site; USD 75,000 - 115,000; Full time

Job summary

PharmEng Technology is seeking a Validation Specialist to assist in validation activities for software updates and new system introductions. This full-time role involves close collaboration with senior specialists and cross-functional teams to ensure quality. The ideal candidate will have a Bachelor's degree in Chemistry or a related field and at least 5 years of relevant experience.

Qualifications

• Minimum 5 years of experience in analytical validation or related field.
• Strong understanding of validation principles and regulatory requirements.
• Experience with validation of analytical systems in a regulated environment.

Responsibilities

• Assist in validation activities for software updates and system decommissioning.
• Support development and execution of validation protocols.
• Conduct risk assessments and ensure compliance with regulations.

Skills

Analytical skills

Problem-Solving

Attention to Detail

Communication

Education

Bachelor's degree in Chemistry, Biochemistry, or related field

Master's degree in Chemistry, Biochemistry, or related field

Job description

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About The Job Validation Specialist

It's an onsite.

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).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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