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Validation Associate Specialist II
3 months ago
Position Overview
The Associate Specialist II in Validation plays a crucial role in supporting the validation initiatives to confirm that the equipment, facilities, utilities, and computer systems employed in product manufacturing are verified for their intended applications.
This position involves the authorship, review, coordination, and execution of qualification and validation documentation related to process equipment, controlled environments, critical utilities, and critical facilities, as well as the decontamination and sterilization of equipment.
Key Responsibilities
- Lead process-related tasks, including the formulation of validation strategies, estimation of timelines and resource needs, and the creation and approval of project validation plans.
- Develop comprehensive and efficient validation test protocols and reports for both new and existing facilities, utilities, and equipment.
- Coordinate, communicate, and ensure the completion of assigned validation activities.
- Utilize instrumentation to conduct various environmental monitoring studies, such as temperature and relative humidity assessments.
- Assist in the evaluation of User Requirements Specifications, Factory Acceptance Tests, and Site Acceptance Tests for facilities, equipment, and utilities.
- Draft documentation, including procedures, summary reports, and status reports related to data integrity as necessary.
- Serve as the system administrator for designated computerized systems.
- Collaborate with cross-functional teams to develop and execute validation activities linked to new equipment and facility upgrades.
- Review and approve documents prepared by the validation team, other departments, and contractors as needed.
- Address and assist in resolving deficiencies or deviations identified during validation activities or related to critical process parameters.
- Support the implementation of existing validation programs to maintain compliance with relevant regulations.
- Participate in audit interviews and assist during audits conducted by regulatory agencies.
Qualifications
Education: Bachelor’s degree in Engineering, Chemistry, Microbiology, or a related field.
Experience: Preferred experience in cGxP validation, particularly in data integrity, installation qualification, operational qualification, and performance qualification.
Skills:
- Strong understanding of engineering principles and related practices, including compliance with governmental regulations such as ISPE, EU, and 21CFR 210, 211, Part 11.
- Experience with systems such as Controlled Temperature units, Critical Utilities, and GMP environment equipment.
- Proven ability to manage complex validation projects in a fast-paced setting.
- Excellent technical writing and verbal communication skills.
- Detail-oriented with the ability to adhere to tight schedules and adapt to dynamic project demands.
- Proficient in Microsoft Word, Outlook, and Excel.
- Familiarity with laboratory instrumentation and control systems used in GMP and/or GLP environments.
- Strong communication and project management abilities.
As part of Emergent BioSolutions Inc., you will be part of a supportive culture that values diverse career opportunities and offers competitive salaries and benefits.