Technical Author: Validation & Compliance Specialist

Envair Technology (previously Total Containment Solutions); Heywood; On-site; GBP 40,000 - 45,000; Full time

Benefits offered by this job

Annual salary £40k-£45k

Annual bonus on performance

24 days holiday + bank holidays

Sick pay scheme

Discounts: Shopping & Leisure

Simply Health cash back plan

Credit Union

Death in service

Nursery voucher salary sacrifice

Job summary

Envair Technology in Heywood, Lancashire, is hiring a Technical Author on a permanent basis. You will produce high-quality validation, compliance, and technical documentation to support design, manufacture and regulatory assurance of products, collaborating across departments to gather requirements and ensure standards are met.

The role involves creating Validation plans, protocols, manuals, and liaising with multiple teams to ensure compliance with CE/UKCA directives in a regulated environment.

Qualifications

• Degree or equivalent in a related field.
• Experience developing validation protocols (IQ/OQ, FAT, FAT, etc.).
• Knowledge of CE/UKCA compliance and related directives.
• GMP experience is desirable.

Responsibilities

• Prepare validation documentation including requirements matrices, design qualifications, FAT, IQOQ, risk assessments, operator manuals.
• Produce standard test protocols and procedure manuals.
• Collaborate with the Compliance Engineer to improve validation documentation processes.
• Liaise with Production, Customer Care, Sales and After Market teams on engineering matters.
• Follow applicable protocols, guidelines and legal standards.
• Engage with customers to understand requirements and respond with compliance information.
• Monitor new/updated regulations and assess impact on products.

Skills

Compliance experience

Attention to detail

Team player

Strong communicator

Proactive

Regulated environments

Education

Degree qualification

GMP experience (desirable)

Job description

Envair Technology in Heywood, Lancashire, is hiring a Technical Author on a permanent basis. You will produce high-quality validation, compliance, and technical documentation to support design, manufacture and regulatory assurance of products, collaborating across departments to gather requirements and ensure standards are met.

The role involves creating Validation plans, protocols, manuals, and liaising with multiple teams to ensure compliance with CE/UKCA directives in a regulated environment.