Production Technology Specialist (Pharmaceutical Manufacturing)

Staff – Non Line Manager level

Role Overview

This position supports the stable, efficient, and compliant manufacture of pharmaceutical products. The role combines process optimization, troubleshooting, technology transfer, and documentation management, with a strong emphasis on GMP and pharmaceutics. The successful candidate will collaborate across departments to maintain high production standards and enable the smooth introduction of new products.

Key Responsibilities

1. Manufacturing Governance & Documentation

• Develop, update, and maintain core manufacturing documents, including process specifications, product history files, and annual product reviews.

• Prepare and revise regulatory?related documentation and SOPs in alignment with internal quality systems.

• Contribute to cross?functional project teams and support implementation of system or process improvements.

2. Process Optimization & Technical Studies

• Design and execute experimental plans aimed at improving production efficiency and process robustness.

• Analyze trial outcomes and prepare technical reports summarizing findings and recommendations.

• Use annual review data to identify opportunities for process refinement.

• Gather and organize information on emerging formulation technologies and prepare technical materials for internal use.

3. Troubleshooting & Issue Prevention

• Investigate manufacturing issues using scientific and formulation?based approaches.

• Lead validation and trial activities from protocol development through final reporting.

• Build knowledge of production equipment and support initiatives to prevent recurring process deviations.

• Prepare supporting documents for meetings and technical discussions.

4. Technology Transfer for New and Existing Products

• Plan and execute technology transfer activities in accordance with established procedures.

• Coordinate with internal stakeholders to ensure smooth handover of processes and documentation.

• Develop validation plans and oversee execution and reporting for transferred processes.

• Produce technical materials required for cross?site or new?product introduction activities.

5. Continuous Improvement

• Identify and implement improvements that enhance productivity, product quality, and operational consistency.

• Propose and execute initiatives that streamline workflows or reduce variability.

• Support multi?skilling and workload balancing within the team.

6. Workplace Safety, Environment, and Compliance

• Participate in safety, environmental, and health?related initiatives.

• Contribute to maintaining a safe and organized workplace through structured housekeeping and risk?prevention activities.

Required Background

Experience

Candidates should have experience in one or more of the following areas:

• Technology transfer for solid oral dosage forms.

• Production technology or manufacturing technology within the pharmaceutical sector.

• Quality control or quality assurance for pharmaceutical products, with interest in transitioning into production technology roles.

Education

• Bachelor’s degree or equivalent in a relevant scientific or engineering field.

Ideal Candidate Profile

We are looking for individuals who can adapt quickly to changing circumstances, think independently, and take initiative to deliver meaningful results. Strong communication skills and the ability to collaborate across functions are essential.

Application Requirement

Applicants are asked to submit materials in both English and Japanese