Job Description

Company:

Colorifix is a biotechnology company that aims to bring a novel, sustainable and environmentally friendly process to the textile dyeing industry by eliminating the use of hazardous chemicals as well as allowing for large savings in water and energy use. Colorifix has been recognised by winning awards in both synthetic biology and fashion, with full information available on our website

We promote and adhere to our company values of Trust, Sustainability, Respect, Inclusivity and Social Conscience.

We are seeking a detail-oriented and proactive Manufacturing Compliance Manager to support and enforce compliance across our bioreactor manufacturing and assembly processes. Working closely with the Production Manager, you will ensure that our systems, components, and vendor inputs meet stringent regulatory, safety, and quality standards for distribution in the UK, Europe, and international markets.

You will take ownership of quality and compliance operations across the full production cycle — from incoming parts and vendor relationships to final product release — and play a key role in standardising processes, documenting quality practices, and supporting external and internal audits. This will be a hybrid role sitting in the Production Line, reporting to our Chief Commercial Officer.

Key Duties and Responsibilities:

1. Production & Process Oversight

   1. Analyse and optimise production line efficiency, safety, and quality.

   2. Implement and manage systems to track part specs, inspections, inventory, and sign-offs etc.

   3. Verify that welding, forming, and manufacturing activities meet regulatory and quality standards.

   4. Maintain compliance with internal SOPs and update SOPs accordingly.

   5. Lead the standardisation of build processes, documentation, and quality assurance protocols for consistent and scalable production.

2. Design & Technical Compliance

   1. Ensure all pressure-containing components (e.g., vessels, piping, valves) are designed in accordance with applicable design codes.

   2. Approve and oversee mechanical calculations, stress analysis, material selection, and testing protocols.

   3. Prepare, review and validate drawings, specifications, and data sheets related to pressure-bearing and other parts.

3. Vendor & Supplier Quality Management

   1. Work with vendors and subcontracted manufacturers to ensure adherence to legal requirements and technical specifications, including part/component conformity.

   2. Manage incoming goods inspections, in-process inspections, final product inspections, and supplier audits.

   3. Oversee QA/QC sign-off processes across supply chains, ensuring adherence to standard operating procedures (SOPs) and quality management system (QMS) requirements.

4. Documentation

   1. Maintain technical files on all bioreactors.

   2. Manage and review vendor documentation, including certificates of analysis, material safety data sheets (MSDS), technical drawings, and quality control records.

   3. Collaborate with Business Development and Implementation teams to provide documentation to our customers for maintenance, installation, commissioning and repair.

   4. Maintain traceable records in line with quality standards, managing version control on all relevant documents.

5. Regulatory Compliance

   1. Ensure all our processes, systems and equipment meet applicable EU/international regulations e.g. the Machinery Directive, Pressure Equipment Directive etc. and their equivalent counterparts in other jurisdictions. Liaise with external advisors as needed to ensure such compliance.

   2. Monitor compliance trends and ensure continued alignment with EU and international standards.

   3. Lead the conformity assessment process, including interaction with Notified Bodies where needed.

   4. Maintain and oversee the technical documentation (technical file) required by applicable regulations.

   5. Prepare and sign EU Declaration of Conformity and ensure appropriate CE marking is affixed.

1. Wider QA/QC & H&S support

   1. Collaborate with internal and external stakeholders involved in ISO 9001 compliance, audits, and continuous improvement initiatives.

   2. Oversee training, and enforcement of our Health & Safety SOPs in Portugal, working with external advisors to ensure alignment with HSE regulations and risk assessments across the shop floor.

Role Requirements:

• Master’s degree in mechanical engineering with a good understanding of chemical and process engineering
• Experience in bioreactor manufacturing
• Knowledge of ISO:9001 or any other suitable ISO standards
• Experience in QC inspections and auditing
• Speak Portuguese and English to conversant level
• Able to prepare technical documents accurately
• Strong team player who is adept at problem solving
• Detail orientated with effective time management and good reporting skills

Desirable Skills:

• Certified welding engineer (CWE) or NDT qualifications
• Health& Safety training/certification
• Project Management (Prince2 or similar)

Title: Manufacturing Compliance Manager

Reports to: Chief Commercial Officer

Location: Vila Nova De Famalicao, Portugal

Holidays: 22 + BH + Birthday

Apply: Please submit your CV and cover letter to recruitment@colorifix.com stating the role that you are applying for in the subject line.

Colorifix is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.