Senior Validation Engineer
Content + Source + Freshness • 16 Dec 2025 • 95% confidence
Offer value
High value attributed to essential responsibilities in validation processes and the influence on regulatory compliance in an FDA-regulated environment.
- Key role in ensuring compliance and quality validation
- Opportunities for cross-functional project work
- Requires extensive and relevant experience
Pros
- Significant role in ensuring product and facility compliance
- Potential for extensive cross-functional collaboration
- Encouragement of professional development in a critical sector
Cons
- Role may demand extended hours due to regulatory pressures
- Experience requirements can limit applicant pool
- On-site presence may impact work-life balance favorability
Who it's for
Senior • In-office/Hybrid
Good fit
- Senior validation professionals focused on compliance
- Individuals with extensive regulatory knowledge
- Candidates excited to work in dynamic project environments
Not recommended for
- New graduates lacking validation experience
- Those preferring remote work only
- Individuals without interest in production environments
Motivation fit
Key skills
About the job
An exciting opportunity has opened our clients validation team for a Senior Validation Engineer (CW). In this role, you will be responsible for delivering on the qualification and validation program at our clients site, which will include planning and execution of validation/requalification activities on critical facilities & equipment. This role will focus on cleanroom environmental monitoring qualification to support changes & expansion of the existing production environment. There may be a requirement to work on shift as part of this role to support critical project milestones.
Key Responsibilities:
* Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
* Develop, review, and approve validation plans, protocols, discrepancies & summary reports.
* Lead the strategy development & associated risk assessments for Environmental Monitoring qualification.
* Lead the planning and execution of environmental qualification activities in accordance with EU & FDA regulations including:
* Environmental Qualification of Grade C cleanrooms.
* Environmental Qualification of Grade A Isolator Filling Lines.
* Support the execution of airflow visualization studies (smoke studies), filter integrity, velocity, and particle monitoring testing activities.
* Coordinate projects and prioritize workload in line with site priorities.
* Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control.
* Collate and report relevant validation data and metrics.
* Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and the clients standards.
* Provide validation support for the clients quality management system, including change control, deviation, and CAPA processes.
* Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
* Attend and contribute to staff meetings and training sessions as required.
* Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.
* Perform all tasks with due care and attention in accordance with Good Manufacturing Practices and the clients requirements, policies, and procedures.
Basic Qualifications:
* Bachelor of Science/Engineering degree or equivalent. Microbiology qualification is desirable
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem-solving ability and excellent oral and written communication skills.
* 5+ years' experience in a similar role.
Preferred Experience:
* Experience qualifying cleanroom facilities and/or HVAC systems.
* Familiarity with Quality and Document Management Systems, including Maximo, Veeva, and Kneat.
* Independent, self-motivated, proactive, organized, able to multi-task in project environments, and skilled in communication and collaboration.
* Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
