Compliance Engineer

Wintech International, LLC; Rochdale; On-site; GBP 35,000 - 55,000; Full time

Job summary

Join a forward-thinking company as a Compliance Engineer, where you will play a crucial role in ensuring that innovative pharmaceutical machinery meets all compliance standards. This position involves preparing essential validation documentation, collaborating with various departments, and monitoring regulatory changes. If you are ambitious, inventive, and passionate about quality assurance in engineering, this opportunity offers a chance to make a significant impact in a growing industry. Contribute to the development of groundbreaking solutions while nurturing your career in a supportive team environment.

Qualifications

• Experience in a compliance role within the pharmaceutical machinery industry.
• Knowledge of medical/pharmaceutical validation requirements is desirable.

Responsibilities

• Prepare validation documentation including Risk Assessment and Method Statements.
• Liaise with Production, Customer Care, and other departments.

Skills

Compliance Engineering

Validation Protocol Development

Risk Assessment

Communication Skills

Education

Degree qualification or equivalent

Job description

Beehive Recruitment is on the lookout for a Compliance Engineer within the Rochdale area. We are working with an industry leader within the manufacturing of pharmaceutical machinery.

They have a broad range of capital equipment which are are used in a number of laboratory settings, including but not limited to the discovery of new therapies for Alzheimer’s or test samples in hospitals.

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

Your Role

As Compliance Engineer, you will support the engineering team with ensuring their 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.

·Work with their 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.

What they are looking for:

·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.

If you would like to be considered for this role, please click apply and one of our dedicated team member will be in touch within 24 hours