Compliance Engineer

Envair Limited; Heywood; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Compliance Engineer to ensure products meet stringent standards and regulations. In this full-time role, you will prepare vital documentation, collaborate with various departments, and monitor compliance requirements. Join a growing team in a state-of-the-art facility where your contributions will directly impact healthcare and pharmaceutical innovations. If you are detail-oriented, have a passion for compliance, and thrive in a team-oriented environment, this is the opportunity for you.

Benefits

Flexible working hours

Annual performance bonus

SimplyHealth cash back plan

Credit Union

Nursery voucher salary sacrifice scheme

Qualifications

• Experience in a compliance role within the medical/pharmaceutical industry.
• Knowledge of CE, UKCA compliance, and associated directives.

Responsibilities

• Prepare validation documentation and standard test protocols.
• Liaise with production and customer care departments.
• Monitor new regulations and standards impacting products.

Skills

Compliance Documentation

Risk Assessment

Validation Protocols

Communication Skills

Team Collaboration

Education

Degree qualification or equivalent

Tools

Requirements Traceability Matrices

Design Qualifications

Factory Acceptance Tests

Installation and Operation Qualifications

Job description

We are currently looking for a Compliance Engineerto join us in Heywood working within a growing team.

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.

This is a permanent, full-time role.

The Benefits

• Hours to be worked flexibly between 8am and 5pm
• Annual bonus based on company performance.
• SimplyHealth cash back plan
• Credit Union
• Nursery voucher salary sacrifice scheme

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

Envair Technology have been manufacturing world class clean air and containment equipment for the healthcare and pharmaceutical industries since 1972. Our mission is to engineer controlled environments that keep people and products safe from airborne hazards.

Our products, including isolators, laminar airflow cabinets and microbiological safety cabinets, are used to prepare chemotherapy treatments for cancer patients, discover new therapies for Alzheimer’s or test samples in hospitals. It means you’ll always finish the day feeling you’ve contributed to something valuable, supporting our NHS and private hospitals throughout Europe.

We’ve enjoyed strong growth in demand for our products for the last few years, and as industry leaders, are always looking to bring new innovations to the market. It’s why we look for people who share our values of taking pride in your work, being ambitious and inventive, nurturing the people around you and collaborating as a team.

Your Role

In your role as a Compliance Engineer, 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 Protocols 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
• Work with our customers to understand their requirements and respond to their requests for compliance information
• Monitor and report on new and updated regulations and standards and their impacts on the company’s products

About You

The ideal candidate would have the following attributes:

• Degree qualification or equivalent, or experience in a compliance role in a similar industry
• Knowledge of medical/pharmaceutical validation requirements – desirable but not essential
• 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
• Strong team player with excellent communication skills, both written and verbal

Envair Technology are an equal opportunities employer. We 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.

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If you can see yourself in this position, send us your CV using the form below. If we think you have the talents we’re looking for, we’ll be in touch within 10 working days.

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