Job Description
The Validation Specialist role is a Fixed Term Contract (FTC) position to support a new API product introduction project at Grange Castle. The successful candidate must work independently and within a flexible team in a demanding, regulated environment, proactively contributing to the delivery of targets within quality, safety and environmental requirements and on schedule.
Key tasks and Responsibilities
Technology Transfer
Lead the introduction of a new process and prepare and execute process validation programs.
Act as the Subject Matter Expert in validation aspects, assessing critical parameters, implementing control strategies and defining cleaning programs.
Support cleaning and process risk assessment programs to determine validation and cleaning approaches.
Prepare and execute plans, protocols and reports associated with process validation and cleaning validation ensuring compliance with current industry regulations.
Quality Systems and GMP
Perform operations in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
Complete required documentation accurately and timely, including records required by SOPs, logbooks, labels and HSE records.
Generate documentation associated with activities, review SOPs, Batch Manufacturing Instruction and Record (BMRs), logbooks, labels, in‑process test documentation and other regulatory documentation.
Safety & Environment
Actively foster a culture of safety awareness in cooperation with other TILGC staff.
Adhere fully to all safety policies, procedures and regulations.
Notify the relevant manager or responsible person of any breach of HSE policy, procedure or regulation in a timely manner.
Training
Actively participate in all training and assessment activities (internal and external) for themselves, manufacturing personnel or other employees.
Ensure timely completion of all SOP training and assessment tasks.
Accurately and promptly record all training and assessment for themselves and other relevant personnel in accordance with TILGC procedures.
Educational Requirements
Primary degree in a scientific discipline.
Relevant Experience
Experience supporting an API Technology Transfer.
3‑5 years experience in a validation role in a regulated environment.
Excellent knowledge of validation regulations and guidelines.
Strong technical understanding of processes and equipment.
Skills and Competencies
Excellent verbal and written communication skills.
Self‑motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
Locations
Grange Castle, Ireland
Worker Type
Employee (Fixed Term)
Time Type
Full time
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