Aseptic Validation & Engineering Officer

Sciensus Pharma Services Limited; Burton upon Trent; On-site; GBP 45,000 - 60,000; Full time

Benefits offered by this job

25 days annual leave + bank holidays

Life Assurance

Contribution based pension scheme

BUPA private medical (subject to grade

Training opportunities

Job summary

Sciensus Pharma Services Limited is establishing a cutting-edge aseptic compounding facility in Burton upon Trent. The Validation & Engineering Officer will support commissioning, qualification and ongoing operation, ensuring facilities, equipment, utilities and processes are validated and inspection-ready.

You will work with Quality and Operations teams to maintain qualification programmes, support investigations and change controls, and drive improvements to deliver safe, high-quality

Qualifications

• Experience supporting qualification and validation activities for facilities, utilities, equipment, processes or computerised systems.
• Experience authoring and executing validation and qualification documentation.
• Knowledge of EU GMP requirements and qualification lifecycle activities including DQ, FAT, SAT, IQ, OQ and PQ.
• Strong analytical, problem-solving and investigation skills
• The ability to manage multiple priorities while maintaining a high level of attention to detail.
• Excellent communication skills and a collaborative approach to working with stakeholders across the business.

Responsibilities

• Support commissioning, qualification and ongoing operation of a new aseptic compounding facility.
• Maintain qualification programmes and support investigations and change controls.
• Help drive continuous improvements to ensure safe, high-quality medicines delivery.
• Maintain GMP compliance and support audits and inspections.
• Ensure the facility continues to operate to the highest quality standards.

Skills

Validation

Qualification docs

GMP knowledge

Audit support

Change control

Quality mindset

Education

Engineering/Pharma Sciences degree

Job description

Sciensus Pharma Services Limited is establishing a cutting-edge aseptic compounding facility in Burton upon Trent. The Validation & Engineering Officer will support commissioning, qualification and ongoing operation, ensuring facilities, equipment, utilities and processes are validated and inspection-ready.

You will work with Quality and Operations teams to maintain qualification programmes, support investigations and change controls, and drive improvements to deliver safe, high-quality