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 Utilities Engineer to ensure the proper maintenance and compliance of facility systems and equipment according to design specifications and GMP standards. The engineer will provide technical expertise for the operation and maintenance of utilities systems, supporting routine operations readiness. Responsibilities include ensuring adherence to standards, supporting the development of commissioning and qualification documents, and ensuring compliance with regulatory requirements. The role also involves troubleshooting technical issues, collaborating with cross-functional teams, and promoting knowledge sharing.
Key Responsibilities
Operational Excellence, Continuous Improvement, and Daily Operations
- Lead and support continuous improvement initiatives for utility system operations, maintenance, and reliability programs.
- Establish key metrics to ensure optimal performance of utility operations.
- Lead and support utility projects by reviewing engineering design documentation and related drawings.
- Lead and support Site Acceptance Tests (SAT), commissioning, and system testing to meet User Requirement Specifications (URS).
- Participate in system walk-downs to ensure reliable utility system operations.
Safety and Quality Compliance Management
- Lead and support audit readiness activities for regulatory inspections to ensure compliance with site and global SOPs, GEP, and GDP requirements.
- Assist in the development, revision, review, and approval of Standard Operating Procedures (SOPs), Risk Assessments, Preventive Maintenance Programs, and Job Plans.
- Lead and support deviation investigations, ensuring appropriate Corrective and Preventive Actions (CAPA) are implemented.
- Lead and support change control activities and continuous improvement initiatives to enhance system reliability and operational performance.
- Actively promote and uphold the Company's Safety Culture.
Sustainability
- Lead and support site sustainability initiatives through analysis of utility and energy consumption data.
- Identify opportunities to optimize utility usage and improve energy efficiency.
- Support the development of business cases and proposals to achieve site sustainability objectives.
- Generate and compile utility consumption data for regulatory authority submissions and internal reporting.
Required Qualifications
- Diploma or Degree in Mechanical, Electrical, Chemical, or related Engineering disciplines.
- Ability to work independently and collaboratively within cross-functional teams.
- Strong interpersonal, communication, and presentation skills.
- Proficient in computer applications and documentation systems.
- Experience working in a highly regulated environment with GMP documentation practices.
- Strong analytical and problem-solving capabilities with the ability to identify improvement opportunities.
- Effective stakeholder management and facilitation skills to achieve project and operational objectives.
- Ability to influence and collaborate positively with peers and stakeholders.
- Familiarity with utilities systems, maintenance programs, commissioning, qualification, and compliance requirements within pharmaceutical, biotech, or related manufacturing environments is preferred.
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.
