Job description:

We are supporting a global life sciences consulting company specialising in quality, compliance and validation in hiring a Mid-to-Senior GMP Validation Consultant.

This opportunity suits a validation professional with hands-on experience in process validation, cleaning validation and equipment/facility qualification, together with strong technical writing skills in English and Japanese.

Role Details

Location: Sasayama, Hyogo Prefecture, Japan

Working arrangement: On-site preferred; remote support will also be considered

Engagement: Candidates seeking a GMP Engineer position on a fixed-term or permanent contract may also be considered, depending on their profile.

Target start: By the end of October 2026; immediate availability preferred

Languages: Business-level English and Japanese required

About the Role

You will support the preparation, review and organisation of critical validation documentation for Chemistry, Manufacturing and Controls (CMC) and regulatory submissions. The role combines validation expertise, data review and technical report writing, working closely with local teams to produce accurate, complete and GMP-compliant documentation.

Key Responsibilities

• Prepare, compile and review validation documentation supporting CMC and regulatory submissions.
• Collect, assess and organise validation data and supporting records.
• Author, update and finalise comprehensive validation reports and technical summaries in English.
• Review documentation covering process validation, cleaning validation and equipment/facility qualification.
• Coordinate with Japanese-speaking teams to gather data, clarify technical information and resolve documentation gaps.
• Ensure documentation complies with applicable GMP requirements and internal quality and regulatory guidelines.

Qualifications:

Required Experience and Skills

• Strong, demonstrated knowledge of current Good Manufacturing Practice (cGMP) requirements.
• Hands-on validation experience in a GMP-regulated environment, covering:

• Proven experience writing, reviewing and managing technical reports for regulatory filings.
• Strong English technical writing and editing skills.
• Business-level Japanese for local team communication and data collection.
• Ability to review complex validation results and translate them into clear, well-structured reports.

Preferred Experience

• Analytical method validation.
• International or multi-country regulatory submissions.

Why is This a Great Opportunity:

Global exposure: Work with an international life sciences consulting company on critical validation and regulatory projects.

Meaningful impact: Contribute to GMP compliance and documentation supporting CMC and regulatory submissions.

Flexible engagement: Freelance preferred, with fixed-term or permanent opportunities considered depending on your profile.

Location flexibility: On-site work in Sasayama, Japan, is preferred, with remote support also considered.

Apply your expertise: Combine hands-on validation knowledge with bilingual communication and technical report writing.