Basic Summary: This is an important role within the QA department, reporting directly to the Validation Manager.
The Validation Engineer will be responsible for reviewing and issuing validation protocols and reports, as well as coordinating the execution of validation activities (process, cleaning, equipment, and computer qualifications) with the relevant departments within the Chanelle Group.Essential Duties and Responsibilities:Contribute to the preparation and review of the Validation Master Plan – Process and Cleaning.Manage the validation requirements of Chanelle, third-party suppliers, and CMOs.Prepare, review, and issue Validation Protocols and Reports, including equipment, cleaning, process, and computer system validation.Maintain and take responsibility for the cleaning validation strategy at Chanelle.Assume responsibility for the Cleaning Validation Master Plan, ensuring it aligns with accepted practices and regulatory authority demands within the EU.Implement Process Validation for new products intended for regulatory submissions, ensuring compliance with proposed registered specifications.Coordinate the execution of validation activities in accordance with protocols, working with Production, Quality Control, and R&D teams.Establish, implement, and oversee validation and revalidation activities.Liaise with contract manufacturing customers to seek their approval for protocols and reports where appropriate.Review and manage Change Control Forms for validation implications.Review and manage Non-Conformances for validation implications.Update existing quality documentation related to validation activities.Identify training requirements in support of validation activities.Ensure completion of validation protocols.Conduct Internal Audits as required.Execute Risk Assessments or Investigation Reports relevant to the role.Maintain the validation documentation system.Lead cross-functional teams to provide knowledge in resolving technical issues.Assist in the preparation and hosting of associated regulatory and customer audits.Skills, Experience & Qualifications: Minimum: Bachelor's degree in science or engineering.Strong verbal and written communication skills, with the ability to work independently in an analytical environment.Proficiency in computer applications such as Word, Excel, and statistical programs.Knowledge of Process and Cleaning Validation.Ability to conduct internal audits.Ability to perform effectively in external audits.Physical Demands/Health & Safety Requirements:Take reasonable care for their own safety, health, and welfare at work, as well as that of others who may be affected by their actions or omissions.Cooperate with Chanelle or its representatives to enable compliance with relevant health and safety statutory provisions.Adhere to safety regulations by ensuring correct usage of PPE in laboratory and production areas.Report to the supervisor or health and safety representative, without unreasonable delay, any defects in plant, equipment, workplace, or work system that might endanger safety, health, or welfare.Keep the work area safe, clean, and tidy.Required Training:Manual Handling training.PC training.