Sigmar recruitment are looking for a Validation Engineer, pharmaceutical company known for its innovative process and product.
As a Validation Engineer will have to manage your activity thorough knowledge and understanding of pharmaceutical solid dosage validation procedures with technical understanding of process equipment and unit processes used in the plant. For that, you will have for duties:
- Assist the Engineering Manager in the coordination, implementation and active participation in Compliance Procedures across the plant,
- Assist and advise the validation of new/existing processes and equipment and liaise with production/scheduling departments on validation issues,
- Review and evaluate FAT/FMEA/FS/URS/SDS/HDS/MR documents and report to ensure a good design basis is established for all validation studies,
- Qualification of equipment, computer system qualification, statistical review of validation data,
- Process validation, qualification of utilities and facilities, cleaning validation, requalification activities,
- Maintaining/Improving the validation system within the company,
- Report and update the Quality Department in Validation Compliance Activities across the plant as and when required,
- Develop/manage and maintain Compliance oversight KPIs,
- Preparation, review and execution of validation plans, CN/RA/DQ/IQ/OQ/PQ/PV/CQ protocols/reports and associated deviations/NCRs for equipment, facility, utility, process, cleaning & computerised systems,
- Liaise with vendors, external consultants & departments on validation issues,
- Conduct Audits on vendors were deemed necessary by the validation committee,
- Assist in the maintenance of production, engineering and quality systems and to ensure that the compliance group projects/activities are executed in a timely manner and in compliance with the overall Quality Management System.
- Ensuring compliance with current industry regulations and guidelines relating to validation
- Participate in cross-functional training, and direct training of validation analysts by maintaining and improving validation SOPs, forms and training manual.
The next Validation Engineer must have a bachelor’s degree in engineering or Life Science Degree is essential. 4 year ‘experience working in a validation role in a regulated environment (GMP) although relative experience in a similar compliance and quality role would be considered. Moreover, experience with Solid Oral Dosage processing experience is highly desirable
To be successful in that position is desirable to have the following softs skills:
- Excellent interpersonal and communication skills, excellent written and verbal communication skills,
- People management experience would be an advantage,
- Strong planning and organization skills,
- A strong technical understanding of processes, equipment and computer systems.
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