Qualification Engineer Job Details | STADA Arzneimittel AG

STADA; Huddersfield; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a Qualification Engineer to ensure compliance with regulatory standards and Good Manufacturing Practices. This role involves planning and executing qualification documentation for manufacturing equipment, utilities, and facilities, while closely collaborating with various teams for smooth implementation. The ideal candidate will have a Bachelor's degree in Engineering or significant practical experience, along with a minimum of one year in a GMP environment. Join a company that values diversity and offers a supportive workplace, competitive salary, and a range of employee benefits to help you thrive.

Benefits

Competitive salary

Annual bonus scheme

25 days annual leave

On-site subsidised canteen

Health benefits through Vitality

Free winter flu jab

Wellbeing support

Electric Car Scheme

Cycle to Work Scheme

Enhanced Family Leave

Qualifications

• Bachelor's degree in Engineering or significant practical experience required.
• Minimum of 1 year experience in a GMP manufacturing environment.

Responsibilities

• Ensure all equipment meets regulatory and performance requirements.
• Coordinate vendors and oversee qualification activities.

Skills

Attention to Detail

Time Management

GMP Documentation

Regulatory Compliance

Education

Bachelor's degree in Engineering

Significant practical experience

Tools

GMP Documentation

Qualification Protocols (URS, IQ, OQ, PQ)

Job description

STADA UK Thornton & Ross is on an exciting growth journey with more than 700 employees being fully committed to our purpose of Caring for People’s Health as a Trusted Partner. Together we are shaping the future of Thornton & Ross by living our values of Integrity, Entrepreneurship, Agility and One STADA.

STADA UK Thornton & Ross - Qualification Engineer

Huddersfield | United Kingdom (GB) | Full-time | Permanent

The Qualification Engineer will play a critical role in ensuring that all equipment, facilities and utilities meet regulatory, operational, and performance requirements. This position focuses on qualification activities, including User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Requalification (RQ), and Periodic Review while ensuring compliance with Good Manufacturing Practices (GMP) and industry standards.

The candidate must be able to plan, develop, and execute qualification documentation (IQ, OQ, PQ, PR) for manufacturing equipment, utilities, and facilities and liaise with vendors for on-site testing.

How You Will Make an Impact

• Work closely with manufacturing, quality assurance, maintenance, and MS&T teams to ensure smooth implementation of qualification activities.
• Work towards re-validation of all critical assets including periodic review and IQ/OQ.
• Generation of KPIs for tracking and closure of qualification activities, CAPA, Change Control and Non Conformances raised through periodic review.
• Provide technical expertise during audits and inspections by regulatory agencies.
• Maintain accurate records of all qualification activities in accordance with company policies and regulatory requirements.
• Coordinate vendors and oversee qualification activities, ensuring proper documentation and execution.

What We Are Looking For

• Bachelor's degree in Engineering, Science or significant practical experience in a related discipline.
• Ideally first experience of working to cGMP principles and regulatory guidelines (e.g. ICH Q8-Q10).
• Minimum of 1 year experience in a GMP manufacturing environment.
• Experience of creating and executing GMP documentation including URS, VP, TRM, DQ, IQ, OQ, PQ.
• Experience with regulatory and/or customer audits.
• Ideally first experience of requalification/qualification of utility systems, sampling booths and cold storage.
• Strong attention to detail and proven time management skills for planning and scheduling work.

How We Care For You

At Thornton & Ross our purpose “Caring for people’s health as a trusted partner” motivates us every day. And what would be a better place than starting with our own employees. Which is why we give much in return:

Competitive salary and annual bonus scheme.

Salary Sacrifice Pension Scheme offering 8% employer contribution rates.

25 days of annual leave plus bank holidays with the potential to buy up to 5 additional days.

On-site subsidised canteen.

Health benefits provided through Vitality Private Medical Insurance.

Free winter flu jab.

Wellbeing support through our Employee Assistance Programme and KYAN Wellbeing – offering free coaching and counselling services for you and your family.

Electric Car Scheme through Octopus Energy, plus free on-site EV charging.

Cycle to Work Scheme.

Enhanced Family Leave.

Plus, many more employee benefits & celebration events.

STADA Group values and promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology, or sexual orientation. We use the strength of our uniqueness to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation, and the promotion of an inclusive working environment. We are looking forward to your application and welcome applications without a pharmaceutical background.