Validation Specialist

6 days ago


Norwood, United States Actalent Full time

Job Summary:

We are looking for a highly skilled and detail-oriented Validation Engineer to join our team. In this role, you will be responsible for validating and qualifying analytical equipment used in our manufacturing and laboratory environments. You will ensure that all equipment complies with regulatory standards and meets the required performance specifications.

? Key Responsibilities:

+ Develop and execute validation protocols (IQ/OQ/PQ) for analytical equipment.

+ Ensure that all validation activities comply with regulatory requirements, including FDA, GMP, and ISO standards.

+ Perform risk assessments and impact analyses for new and existing equipment.

+ Coordinate with cross-functional teams to support equipment commissioning and qualification.

+ Prepare and review validation documentation, including validation plans, protocols, and reports.

+ Troubleshoot and resolve equipment-related issues to ensure continuous compliance and operation.

+ Maintain detailed and accurate records of validation activities.

+ Train and mentor staff on validation procedures and best practices.

+ Stay updated with industry trends and advancements in validation technology.

Qualifications:

+ Bachelors degree in Engineering, Life Sciences, or a related field.

+ Proven experience in validation of analytical equipment within a GMP-regulated environment.

+ Strong knowledge of validation principles and regulatory requirements (FDA, GMP, ISO).

+ Proficiency in developing and executing IQ/OQ/PQ protocols.

+ Excellent problem-solving and analytical skills.

+ Ability to work independently and as part of a team.

+ Strong organizational skills and attention to detail.

+ Excellent written and verbal communication skills.

+ Proficient in Microsoft Office (e.g., Excel, Word, PowerPoint).

Preferred Qualifications:

+ Experience with specific analytical instruments (e.g., HPLC, GC, UV-Vis).

+ Advanced degree in Engineering, Life Sciences, or a related field.

+ Certification in validation or quality assurance.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.



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