Aseptic Validation & Engineering Specialist

Sciensus; Burton upon Trent; Sur place; GBP 40 000 - 65 000; Plein temps

Avantages offerts par ce poste

25 days annual leave + bank holidays

Yearly pay reviews.

Life Assurance

Annual company event.

Refer a friend scheme.

Contribution based pension scheme.

BUPA private medical (Subject to grade

Salary sacrifice schemes (Electrician?

Discount & cashback portal.

Internal & External training opportuni

Access to various well-being initiativ

Paid volunteer day

Résumé du poste

Sciensus in Burton upon Trent is seeking a Validation & Engineering Officer to join the Compounding team and help shape a new MHRA-licensed aseptic facility. You will support commissioning, qualification and ongoing operation to ensure compliant, validated, inspection-ready processes.

You will work with Quality and Operations to maintain qualification programs, lead change controls, investigations and continuous improvements, helping deliver safe, high-quality medicines and patient care.

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
• Ability to manage multiple priorities with attention to detail
• Excellent communication and collaboration with stakeholders

Responsabilités

• Support commissioning, qualification and ongoing operation of the new aseptic compounding facility.
• Help ensure facilities, equipment, utilities and processes remain compliant, validated and inspection ready.
• Maintain qualification programmes and support investigations and change controls.
• Assist audits and inspections to ensure GMP compliance.
• Drive continuous improvements for safe, high-quality medicines

Connaissances

GMP compliance

Validation lifecycle (DQ, IQ, OQ, PQ)

Qualification & validation docs

Analytical skills

Stakeholder collaboration

Formation

Engineering degree or related

Pharmaceutical Sciences or Life Sciences background

Outils

CSV (Computerised Systems Validation)

GxP documentation tools

Description du poste

Sciensus in Burton upon Trent is seeking a Validation & Engineering Officer to join the Compounding team and help shape a new MHRA-licensed aseptic facility. You will support commissioning, qualification and ongoing operation to ensure compliant, validated, inspection-ready processes.

You will work with Quality and Operations to maintain qualification programs, lead change controls, investigations and continuous improvements, helping deliver safe, high-quality medicines and patient care.