Position Overview
The Technical Specialist, Manufacturing Operations is responsible for providing technical and operational support across the manufacturing lifecycle, encompassing Operational Readiness, Operational Run, and Operational Release activities. This role plays a critical part in ensuring compliant, efficient, and uninterrupted GMP manufacturing operations through technology transfer support, deviation management, CAPA implementation, investigation leadership, and batch disposition support.
The successful candidate will collaborate closely with Manufacturing, Quality, MSAT, Engineering, and Supply Chain teams to ensure operational excellence, regulatory compliance, and timely product delivery.
Key Responsibilities
- 1. Operational Readiness
- Support manufacturing readiness activities for technology transfers, new product introductions, and process campaigns by:
- Developing, reviewing, and revising Master Batch Records (MBRs).
- Preparing and managing Change Requests (CRs) and associated documentation.
- Creating, updating, and maintaining GMP documentation, procedures, and work instructions.
- Facilitating and supporting operational risk assessments.
- Coordinating and delivering pre-campaign training activities.
- Ensuring manufacturing processes, documents, and systems are ready prior to campaign execution.
- Supporting cross-functional teams in readiness reviews and manufacturing preparations.
- 2. Operational Run
- Provide technical support during manufacturing campaigns by:
- Assessing and managing manufacturing deviations through the Deviation Review Board (DRB) process.
- Leading and tracking Corrective and Preventive Actions (CAPAs).
- Managing assigned tasks, action items, and compliance commitments.
- Supporting CSCC investigations and issue resolution.
- Managing rejected materials and associated investigations.
- Participating in internal and external audits related to manufacturing operations and investigations.
- Collaborating with Manufacturing, Quality, Engineering, and MSAT teams to resolve process-related issues.
- Monitoring operational trends and identifying opportunities for continuous improvement.
- 3. Operational Release
- Support product release activities through investigation and quality review by:
- Leading deviation investigations and trend investigations.
- Performing comprehensive root cause analysis (RCA).
- Conducting product impact assessments to support batch disposition decisions.
- Identifying, implementing, and verifying CAPA effectiveness.
- Preparing clear, concise, and technically sound investigation reports.
- Supporting timely lot disposition and product release activities.
- Ensuring compliance with GMP requirements and internal quality systems.
Required Qualifications
- Bachelor's Degree in Biotechnology, Life Sciences, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline.
- Minimum 3-8 years of experience in GMP pharmaceutical, biotechnology, biologics, vaccine, or cell therapy manufacturing environments.
- Experience supporting manufacturing operations, quality systems, or technical operations.
- Hands-on experience with deviation investigations, CAPA management, and change control processes.
- Experience supporting technology transfers and manufacturing campaigns is preferred.
- Familiarity with batch release processes and product disposition activities is advantageous.
Why join us
- Generous Leave Policy.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
