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Job Summary: We are seeking a highly experienced Senior Validation Engineer/Specialist with significant process validation (PPQ) experience to join our team on a temporary 3-6 month assignment. As a Senior Validation Engineer/Specialist, you will play a crucial role in supporting tech transfer and process validation projects within our organization. Your expertise in process validation and knowledge of regulatory requirements will ensure the successful transfer of manufacturing processes and the validation of critical equipment. This position may require flexibility in working hours, including evening or night shift coverage and occasional weekend work, based on the manufacturing schedule. This is a challenging opportunity to contribute to the growth and success of our company.

Responsibilities:

• Lead and execute process validation activities, including process performance qualification (PPQ), in accordance with regulatory requirements, industry best practices, and internal quality standards.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, engineering, and regulatory affairs, to ensure effective tech transfer and successful validation of manufacturing processes.
• Develop and execute validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), for equipment, facilities, and processes.
• Collect and analyze validation data, perform statistical analysis as needed, and generate comprehensive validation reports to document results and conclusions.
• Identify and evaluate critical process parameters and process controls to ensure consistent and reliable manufacturing processes.
• Collaborate with internal teams to identify process improvements and implement corrective and preventive actions (CAPAs) based on validation findings.
• Stay updated on regulatory requirements and industry trends related to process validation and ensure compliance with applicable regulations and guidelines.
• Participate in risk assessments and assist in the development of risk mitigation strategies for manufacturing processes.
• Provide technical guidance and support to junior team members and contribute to their professional development.
• Participate in internal and external audits and inspections related to process validation activities.
• Maintain accurate and up-to-date documentation of validation activities, including protocols, reports, and validation master plans.

Qualifications:

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field. Advanced degree is a plus.
• Significant experience (minimum 5 years) in process validation, including hands-on experience with process performance qualification (PPQ) activities.
• In-depth knowledge of regulatory requirements, including FDA and ICH guidelines, related to process validation and equipment qualification.
• Strong understanding of statistical analysis techniques and their application in process validation.
• Experience with tech transfer and validation of pharmaceutical manufacturing processes is highly desired.
• Proficiency in executing validation protocols, generating validation reports, and analyzing validation data.
• Excellent problem-solving skills and the ability to identify and address potential issues during process validation.
• Strong organizational skills and the ability to manage multiple projects simultaneously.
• Effective communication skills, both written and verbal, with the ability to collaborate and influence cross-functional teams.
• Flexibility in working hours, including the ability to work evening or night shifts and occasional weekends based on manufacturing schedule requirements.
• Familiarity with quality management systems (e.g., ISO 13485) and risk assessment methodologies is a plus.
• Experience with sterile manufacturing processes is an advantage.

If you are a highly skilled Senior Validation Engineer/Specialist with significant process validation experience, we invite you to apply for this temporary assignment. Join our team and contribute to the successful tech transfer and validation of critical manufacturing processes. This is an exciting opportunity to work on challenging projects and make a meaningful impact in the pharmaceutical industry.

Qualifications:

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field. Advanced degree is a plus.
• Significant experience (minimum 5 years) in process validation, including hands-on experience with process performance qualification (PPQ) activities.
• In-depth knowledge of regulatory requirements, including FDA and ICH guidelines, related to process validation and equipment qualification.
• Strong understanding of statistical analysis techniques and their application in process validation.
• Experience with tech transfer and validation of pharmaceutical manufacturing processes is highly desired.
• Proficiency in executing validation protocols, generating validation reports, and analyzing validation data.
• Excellent problem-solving skills and the ability to identify and address potential issues during process validation.
• Strong organizational skills and the ability to manage multiple projects simultaneously.
• Effective communication skills, both written and verbal, with the ability to collaborate and influence cross-functional teams.
• Flexibility in working hours, including the ability to work evening or night shifts and occasional weekends based on manufacturing schedule requirements.
• Familiarity with quality management systems (e.g., ISO 13485) and risk assessment methodologies is a plus.
• Experience with sterile manufacturing processes is an advantage.

If you are a highly skilled Senior Validation Engineer/Specialist with significant process validation experience, we invite you to apply for this temporary assignment. Join our team and contribute to the successful tech transfer and validation of critical manufacturing processes. This is an exciting opportunity to work on challenging projects and make a meaningful impact in the pharmaceutical industry.