Job Details
Posted 5 August, 2026
Job Id: 629670
GMP Validation Consultant / GMP Engineer (Freelance)
Job Description
An exciting opportunity is available for an experienced GMP Validation Consultant (or GMP Engineer) to support a specialist pharmaceutical manufacturing project in Japan.
This is a hands-on validation role supporting CMC and regulatory documentation activities, with responsibility for preparing, reviewing and organising critical validation documentation within a GMP-regulated environment.
This assignment is initially expected to run for approximately six weeks, with the potential for extension based on project requirements.
The Opportunity
Working alongside a highly experienced technical team, you will play a key role in supporting regulatory readiness through validation documentation, technical report writing and compliance activities.
This role would suit an experienced consultant who enjoys combining practical GMP validation knowledge with strong technical writing capability.
Key Responsibilities
- Prepare, compile and review validation documentation supporting CMC and regulatory submissions.
- Collect, review and organise validation data from multiple stakeholders.
- Write, update and finalise Validation Reports and technical summaries.
- Ensure documentation complies with current GMP requirements and internal quality standards.
- Support validation activities across manufacturing processes and GMP systems.
- Collaborate with cross-functional teams to ensure documentation is accurate, complete and inspection-ready.
Required Experience
We are looking for candidates with demonstrated experience in:
- GMP-regulated pharmaceutical manufacturing.
- Process Validation (PV).
- Cleaning Validation.
- Equipment & Facility Qualification (DQ, IQ, OQ and PQ).
- Validation report writing.
- CMC or regulatory documentation.
- Technical writing within regulated environments.
Highly Desirable
- Analytical Method Validation.
- Experience supporting international regulatory submissions.
- Consultancy or contractor experience within GMP manufacturing.
Candidate Profile
The successful candidate will ideally have:
- Mid to Senior level GMP validation experience.
- Excellent technical writing skills.
- Business-level English.
- Business-level Japanese.
- The ability to work with both local and international stakeholders.
- Availability to commence in mid-August.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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