Envair: Compliance Engineer 2

We are currently looking for a permanent Compliance Engineer to join us in Heywood, as our person responsible for the creation of key validation documentation for clean air equipment, manufactured for the pharmaceutical and educational sectors.

If you have knowledge of medical/pharmaceutical validation or have worked in other highly regulated industries, a track record in the development of validation protocols such as risk assessments, design qualifications, Factory Acceptance Testing (FAT), Installation Qualification, Operational Qualification (IQOQ) and Operator Manuals and have ideally worked under Good Manufacturing Practice (GMP) standards, this is an exciting opportunity to join the engineering function of a long-established business.

You will have the chance to shape and influence a fantastic product offering that is making a difference in hospitals, laboratories, pharmaceutical companies, research institutes and manufacturing facilities across the globe.

The Benefits

• Annual salary circa £35,000 - £45,000, depending on experience
• Annual bonus based on group performance
• Retail and leisure discounts
• Enhanced company sick pay
• 24 days holiday plus Bank Holidays

Location

Our clean, bright 63,000 sq.ft site in Heywood, Lancashire is the largest containment factory in the North West, just minutes from the M66 and M62. We have invested £1m in our facility, with state of the art machinery and great staff facilities including showers, canteen and plenty of on-site parking.

About us

Part of Envair Technology, Envair is a specialist provider of clean air and containment facilities for healthcare, research laboratories, biotechnology and the pharmaceutical industry. With over 50 years of global success, we are certified to BS EN ISO 9001: 2015 standards and are recognised as a leader in the cleanroom, specialist laboratory and containment engineering market. Our extensive range of products includes negative pressure containment isolators, sterility isolators, vertical and horizontal airflow cabinets, microbiological safety cabinets, fume cupboards, glove boxes, containment booths and air showers.

We are proud of our dedicated employees, many of whom have been with us for many years, as well as our management team, who are considered to be some of the best in the industry. As part of this skilled team, you will have the opportunity to drive the success of an integral business function, which in turn, will make a positive impact on our organisation as a whole.

Your Role

As our Compliance Engineer, you will support our engineering team with ensuring our standard and bespoke products are tested in accordance with the appropriate directives and standards. Specifically, you will:

• Prepare the required validation documentation including the Requirements Traceability Matrices, Design Qualifications, Factory Acceptance Tests, Installation and Operation Qualifications, Operator Manuals, Risk Assessment and Method Statements.
• Produce Standard Test Protocol’s and procedure manuals.
• Work closely with the Head of Engineering to scope out and implement continuous improvement in the production and management of validation documentation.
• Liaise directly with other areas of the business such as the Production, Customer Care, Sales, and After Market departments on behalf of the Engineering Team.
• Work according to the applicable protocols, guidelines and legal standards as required.
• Respond to customer requests for compliance information.
• Monitor and report on new and updated regulations and standards and their impacts on the company’s products.

About You

To join us, you will need:

• To be qualified to degree level or equivalent
• Knowledge of medical/pharmaceutical validation requirements (desirable)
• A proven track record in the development and execution of validation protocols, such as risk assessments, design qualifications, FAT, IQOQ, and Operator Manuals or similar
• Working knowledge of CE, UKCA compliance and any associated directives; including but not limited to Low Voltage, EMF, and ATEX
• Experience working under GMP- desirable but not essential
• Ability to plan, schedule and coordinate activities effectively, managing your own tasks through to completion
• To be a strong team player with excellent communication skills, both written and verbal.

Envair are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.