Validation Specialist

Mentor Technical Group; Town of Texas (WI); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is looking for a Validation Specialist to join their team. This role focuses on validating manufacturing processes, equipment, and systems to ensure compliance with the highest quality standards. The ideal candidate will have a strong background in pharmaceutical validation processes and regulatory requirements. Join a forward-thinking company that values collaboration and offers a dynamic work environment where your contributions will make a significant impact in ensuring safety and efficacy in the regulated industry.

Qualifications

• Bachelor's degree in Engineering or Life Sciences is required.
• Experience in validation within the pharmaceutical or biotech industry.

Responsibilities

• Develop and document validation protocols for processes and equipment.
• Ensure compliance with regulatory requirements and company standards.

Skills

Pharmaceutical Validation

Regulatory Compliance

Analytical Skills

Problem-Solving

Communication Skills

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Job description

Validation Specialist at Mentor Technical Group

Join to apply for the Validation Specialist role at Mentor Technical Group.

Mentor Technical Group (MTG) provides comprehensive technical support and solutions for the FDA-regulated industry, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, USA, we serve clients in six global markets: the United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Job Summary:

We are seeking a skilled Validation Specialist with expertise in pharmaceutical validation processes to join our team. The ideal candidate will be responsible for validating manufacturing processes, equipment, and systems to ensure compliance and quality standards are met.

Key Responsibilities:

• Develop, execute, and document validation protocols for equipment, processes, and systems
• Ensure validation activities comply with regulatory requirements and company standards
• Collaborate with cross-functional teams to support validation projects
• Review and approve validation documentation
• Participate in audits and inspections related to validation activities
• Maintain validation master plans and related documentation

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field
• Experience in validation within the pharmaceutical or biotech industry
• Knowledge of regulatory requirements such as FDA, EMA, etc.
• Strong analytical and problem-solving skills
• Excellent communication skills and attention to detail
• Ability to work independently and collaboratively

Mentor Technical Group is an equal opportunity employer, offering consideration to all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, veteran status, disability, or any other protected characteristic.