No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team.
Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
The MSAT Specialist will play a critical role in supporting technical transfer and validation activities within the organization. This position involves collaboration with cross-functional teams to ensure the efficient and timely creation, review, and completion of technical and validation documentation in alignment with organizational guidelines and standards.
The MSAT Specialist will play a critical role in supporting technical transfer and validation activities within the organization. This position involves collaboration with cross-functional teams to ensure the efficient and timely creation, review, and completion of technical and validation documentation in alignment with organizational guidelines and standards.
Key Responsibilities:
- Technical Documentation Support:
- Assist the Technical Transfer Lead and Technical Stewards in preparing a wide range of technical transfer documentation, including but not limited to:
- Master Process Transfer Protocols (MPTP)
- Detailed Failure Mode and Effect Analysis (dFFA)
- SSPD
- Quality Risk Assessments (QRA)
- Technical Run Monitoring Protocols/Reports
- Manufacturing Control Strategies (MCS)
- Validation Control Strategies (VCS)
- Process Validation Support:
- Collaborate with the Validation Lead to draft, review, and finalize process validation protocols and reports to ensure compliance with regulatory and organizational requirements.
- Cross-Functional Collaboration:
- Coordinate with internal stakeholders, including cross-functional teams within organization, to facilitate the writing, review, and approval process for technical transfer documentation.
- Timely Documentation Delivery:
- Ensure the completion of technical transfer documentation within established timelines and in accordance with company guidelines, maintaining high-quality standards throughout the process.
- Support for Additional Tasks:
- Provide assistance to the Technical Transfer Team by undertaking other related assignments as directed by the Senior Technical Transfer and Technology Lead.
Qualifications and Skills:
- Strong technical writing skills and attention to detail
- Proficiency in creating and managing technical and validation documents
- Excellent organizational and time management abilities to meet deadlines
- Effective communication skills for collaboration with cross-functional teams
- Familiarity with regulatory guidelines and standards in a pharmaceutical or biopharmaceutical manufacturing environment
This role is ideal for professionals who are detail-oriented, collaborative, and committed to ensuring the success of technical and validation processes within a dynamic and innovative environment.
Qualifications and Skills:
- Educational Background:
- Bachelor’s or Master’s degree in Chemical Engineering, Biotechnology, Life Sciences, or a related field.
- Professional Experience:
- At least 3-5 years of experience in manufacturing science and technology (MSAT), technical transfer, process validation, or a related field within the pharmaceutical or biopharmaceutical industry.
Why Join Us?
We believe in supporting our employees both professionally and personally. As a valued team member, you will enjoy a comprehensive benefits package, including:
- Generous Leave Policy: 18 days of annual leave to support work-life balance.
- Elderly Care Leave: 3 additional days to care for aging family members.
- Health and Wellness Coverage: Comprehensive medical benefits, including dental coverage.
- Professional Development: Opportunities for continuous learning and growth within the organization.
- Employee Support Programs: Access to resources and tools to help you thrive in your role.
