Validation & Engineering Officer

Sciensus Pharma Services Limited; Burton upon Trent; Sur place; GBP 45 000 - 60 000; Plein temps

Avantages offerts par ce poste

25 days annual leave + bank holidays

Life Assurance

Contribution based pension scheme

BUPA private medical (subject to grade

Training opportunities

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Validation

Qualification docs

GMP knowledge

Audit support

Change control

Quality mindset

Formation

Engineering/Pharma Sciences degree

Description du poste

Burton on Trent, Staffordshire, United Kingdom

Our mission at Sciensus is simple: to give patients control of their health through knowledge, choice, convenience and connection.

To help us be successful in our mission we are looking for a Validation & Engineering Officer to join our Compounding team.

40 hours per week / Site-Based / Perm Contract

As we prepare to launch a new MHRA-licensed aseptic compounding facility, we have an exciting opportunity for a Validation & Engineering Officer to help shape, qualify and support a state-of-the-art pharmaceutical manufacturing environment from the ground up

You’ll support the commissioning, qualification and ongoing operation of our new aseptic compounding facility, helping to ensure facilities, equipment, utilities and processes remain compliant, validated and inspection ready.

Working closely with the Quality and Operations teams, you’ll contribute to validation activities, maintain qualification programmes, support investigations and change controls, and help drive continuous improvements that ensure the safe and reliable delivery of medicines to patients.

You’ll also play an important role in maintaining GMP compliance, supporting audits and inspections, and ensuring the facility continues to operate to the highest quality standards.

What’s in it for you?

• The opportunity to help deliver and support a brand-new pharmaceutical compounding facility.
• Exposure to major commissioning, validation and qualification projects.
• A collaborative and innovative working environment.
• The chance to make a real difference to patient care through the delivery of safe, high-quality medicines.

What’s required to be successful?

You’ll be a technically minded professional with experience in a GMP-regulated pharmaceutical environment and a passion for quality, compliance and patient safety. *

We’re particularly interested in candidates who have:

• 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.

It would be great if you also have

• Experience within aseptic manufacturing or pharmaceutical compounding environments.
• Knowledge of cleanroom qualification, HVAC systems, critical utilities or environmental monitoring systems.
• Exposure to isolator technology, VHP decontamination systems or Computerised Systems Validation (CSV).
• An HNC, HND, degree or equivalent qualification in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences or a related discipline

Why work for Sciensus?

Sciensus is a leading European life sciences organisation with over 30 years of experience, helping over 240,000 patients a year gain access to beneficial treatments and life-changing medicines.

We empower patients with digital tools to take control of their treatments, report on symptoms, quality of life, and access support through their care journey. We blend this with personalised support services from our team of over 700 registered clinical staff.

Every colleague at Sciensus contributes to improving the patient experience. Whether you’re supporting operations behind the scenes or delivering care directly to patients, your work makes a real difference.

What we offer our people?

We work hard to make sure colleagues feel motivated, developed, and recognised for the great work they do.

This role offers a competitive salary alongside a comprehensive benefits package, including:

• 25 days annual leave + bank holidays
• Yearly pay reviews.
• Life Assurance
• Annual company event.
• Refer a friend scheme.
• Contribution based pension scheme.
• Access to BUPA private medical (Subject to grade or length of service)
• Salary sacrifice schemes (Electric vehicle/Bike to work/Tech)
• Discount & cashback portal.
• Internal & External training opportunities
• Access to various well-being initiatives
• Paid volunteer day

At Sciensus, our values shape who we are, what we stand for and how we work every day. We’re Passionate about Patients, putting patient care and experience at the heart of every decision we make. We’re Ambitious to be the Best, continuously learning, improving and innovating to deliver exceptional outcomes. And we believe Together, We Win, building trusted relationships, embracing diverse perspectives and achieving more through collaboration.

What happens next?

Advert Closing Date – TBC

Process – Initial call with one of our talent team before interviews take place.

Start date - TBC