Location
Bradford on Avon, Wiltshire | United Kingdom
Job description
I'm currently recruiting a Validation Specialist on behalf of one of our clients, a very well known biotech organisation.
About the role:
As a CQV Specialist, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and facilities. Working closely with cross-functional teams, you will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes to meet regulatory requirements and industry standards.
Key Responsibilities:
- Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
- Perform risk assessments and impact assessments to ensure comprehensive validation strategies.
- Collaborate with engineering, manufacturing, quality, and regulatory teams to ensure alignment and compliance with cGMP guidelines and regulatory requirements.
- Lead validation activities for new equipment installations, process improvements, and facility expansions.
- Execute validation studies, including but not limited to equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and computer system validation.
- Analyze validation data, generate reports, and make recommendations for process improvements and corrective actions.
- Support regulatory inspections and audits by providing documentation and participating in inspections as necessary.
- Stay informed about current industry trends, regulatory expectations, and best practices related to validation and compliance.
Qualifications:
- Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
- Minimum of 2 years of experience in commissioning, qualification, and validation within the biotech or pharmaceutical industry.
- Strong understanding of cGMP regulations.
- Experience with validation documentation, including protocols, reports, risk assessments, and standard operating procedures (SOPs).
- Excellent analytical, problem-solving, and decision-making skills.
- Ability to work effectively in a fast-paced, dynamic environment with multiple priorities and tight deadlines.
- Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
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Job tags
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