About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
We are seeking a skilled and detail-oriented Project Engineer to manage the qualification of the Building Management System (BMS) for QC rooms. The ideal candidate will be responsible for ensuring that the QC rooms BMS meets regulatory, quality, and operational requirements through meticulous planning, execution, and documentation. This role involves close collaboration with cross-functional teams, external vendors, and contractors to deliver a fully compliant and operational system.
Key Responsibilities
- Lead the end-to-end qualification process of the QC room Building Management System (BMS), including planning, execution, and validation activities.
- Develop and review protocols, risk assessments, and qualification documentation to ensure compliance with GMP standards and regulatory requirements.
- Oversee the installation, commissioning, and operational qualification (IQ/OQ) of the BMS to verify proper functioning and adherence to specifications.
- Collaborate with stakeholders to resolve technical challenges during the qualification process.
- Create and manage project timelines, budgets, and resource allocations to ensure successful delivery of the BMS qualification project.
- Monitor project milestones and deliverables, providing updates to stakeholders on progress, risks, and mitigation plans.
- Coordinate with vendors, contractors, and internal teams to ensure smooth execution of project activities.
- Conduct risk assessments and implement mitigation strategies to address potential project challenges.
- Ensure all qualification activities align with GMP, cGMP, and other relevant regulatory guidelines.
- Maintain accurate and complete documentation, including qualification reports, deviations, and change controls.
- Support internal and external audits by providing necessary documentation and technical expertise.
- Work closely with Quality Assurance, Engineering, Facilities, and other teams to align project objectives with organizational goals.
- Act as a key point of contact for external vendors and contractors involved in the BMS qualification process.
Required Qualifications
- Bachelor’s degree in engineering, Biotechnology, or a related field.
- Minimum of 3 years of experience in project management or engineering within a pharmaceutical or biotech environment.
- Experience in qualification and validation of BMS systems or similar automated systems.
- Strong understanding of GMP and cGMP requirements.
- Proficiency in project management tools (e.g., MS Project, Smartsheet).
- Excellent problem-solving, organizational, and communication skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Familiarity with HVAC systems, controls, and automation in regulated environments.
- Knowledge of risk assessment methodologies and technical troubleshooting.
Why join us?
- Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
- 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.