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Validation Associate Specialist II
3 months ago
Job Overview
This position is pivotal in supporting the validation initiatives to confirm that the equipment, facilities, utilities, and computer systems used in product manufacturing are validated for their intended applications.
The Associate Specialist II, Validation is tasked with authoring, reviewing, coordinating, and executing qualification and validation documentation, which encompasses process equipment, controlled environments, critical utilities, critical facilities, and the decontamination/sterilization of equipment.
Key Responsibilities
Reasonable accommodations will be provided to enable individuals with disabilities to perform essential functions.
- Manage process-related activities, including the formulation of validation strategies, estimation of validation timelines and resource needs, creation and approval of project validation plans, and development of effective validation test protocols and reports for both new and existing facilities, utilities, and equipment.
- Coordinate, communicate, and complete assigned validation tasks efficiently.
- Utilize instrumentation to conduct various environmental monitoring studies (e.g., temperature, relative humidity).
- Assist in reviewing User Requirements Specifications, Factory Acceptance Tests, and Site Acceptance Tests for facilities, equipment, and utilities.
- Draft documents such as procedures, summary reports, and status reports related to data integrity as necessary.
- Act as the system administrator for designated computerized systems.
- Collaborate with cross-functional teams in the development and execution of validation activities associated with new equipment, system, and facility upgrades.
- Review and approve documents prepared by the validation team, other departments, and contractor organizations as required.
- Assist in resolving and closing deficiencies/deviations identified during validation activities or related to critical process parameters.
- Support the implementation of existing Validation programs to ensure ongoing compliance with necessary regulations.
- Participate in audit interviews and support audits conducted by regulatory agencies.
Education, Experience & Skills
Requirements
- Bachelor's degree in Engineering, Chemistry, Microbiology, or a related field.
- Preferred experience in cGxP validation, particularly in data integrity, installation qualification, operational qualification, and performance qualification.
- Familiarity with investigations and root cause analysis principles.
- Exceptional technical writing and verbal communication skills.
- Proven ability to manage complex validation projects in a fast-paced environment.
Skills
- Strong knowledge of engineering practices and related regulations, including ISPE, EU, 21CFR 210, 211, and Part 11.
- Experience with systems such as Controlled Temperature units, Critical Utilities, Facilities, and equipment, preferably in a GMP environment.
- Demonstrated success in technical proficiency, creativity, collaboration, and independent thought.
- Ability to make decisions exercising judgment within generally defined practices and policies for selecting methods and techniques for solutions.
- Excellent attention to detail, with the capacity to work under tight schedules.
- Ability to adapt to a dynamic project schedule with varying levels of complexity.
- Advanced skills in Microsoft Word, Outlook, and Excel.
- Experience with laboratory instrumentation/equipment and control systems used in GMP and/or GLP environments.
- Strong communication and project management skills.
- Adaptable and flexible.
- Pre-employment medical assessment is required.
As part of Emergent BioSolutions Inc., you will be part of a team that values diversity and offers a supportive culture, competitive salaries, flexible work arrangements, and an extensive benefits package.
