Job Purpose:
The role serves as a subject matter expert responsible for validating, optimizing and maintaining robust manufacturing and cleaning processes to ensure consistent production of safe, effective and cost efficient products. This role provides technical expertise to drive process efficiency, compliance with regulatory and quality standards, and timely technical transfers and validations, while supporting investigations, continuous improvement and site readiness. Through strong cross functional collaboration and execution excellence, the role directly contributes to site supply reliability, product quality and overall business performance.
Key Responsibilities:
Provide subject matter expertise for process validation, verification and lifecycle maintenance activities for manufacturing and cleaning processes.
Plan, execute and document process and cleaning validation activities to ensure manufacturing capability and prevent cross contamination.
Support Continued Process and Cleaning Verification (CPV/CV) through monitoring of critical process parameters to maintain process control and reduce variability.
Execute process confirmations and periodic product reviews to support the Product Control Strategy and ongoing compliance.
Analyze process data and trends to identify improvement opportunities and support product and process optimization projects.
Support technical transfers, equipment or IM qualification activities, and related assessments to enable successful new product introductions and changes.
Lead or support root cause investigations and change impact assessments, ensuring effective corrective actions, appropriate technical rationale and compliant documentation. Collaborate with Operations, Quality, Engineering and other MSAT SMEs to balance compliance, cost and supply risk and to support audits and regulatory expectations.
Author, review and maintain technical documents, protocols, reports and assessments required to support validated state and effective knowledge management.
Ensure the provisions of the employer regarding Health, Safety and Environment regulations in their area of competence, in accordance with EHS&S Corporate Standards; in particular ensuring proper use of personal protection equipment and applying the proper escalation process in case of any unforeseen risk, for the appropriate actions to be taken.
*Future scope of job and working location will be determined by company.
Basic Qualification
Skill
Knowledge of GMP/GDP and good documentation practices, with experience supporting internal/external audits.
Cross-functional delivery and risk/project management: Proven ability to work effectively across functions to coordinate technical activities, manage priorities and mitigate risk in a GMP manufacturing environment.
Technical communication and collaboration: Ability to influence through expertise, communicate complex technical information clearly, and work effectively with Operations, Quality, Engineering and other stakeholders.
Results-oriented mindset and continuous improvement: Committed to achieving business and quality objectives through data-driven decision making, innovation, and a focus on continuous improvement.
Problem-solving and critical thinking: Ability to analyze complex situations, identify practical solutions, and make informed decisions based on data and metrics.
Experience
At least 5 years of experience in pharmaceutical industries.
Education/certification/Language
Education: bachelor’s degree or equivalent in Scientific field (e.g. Pharmaceutical Chemistry and Technologies, Chemistry, Biology)
Preferred Qualification
Skill・Experience
Technical manufacturing expertise: e.g. technical aspects of the Product Lifecycle including Scale Up, Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, Process/Cleaning validation, Contamination Control and change control
Education/certification/Language
Fluent spoken and written…