Job Description

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 Utilities Engineer to ensure the proper maintenance and compliance of facility systems and equipment according to design specifications and GMP standards. The engineer will be the Subject Matter Expert (SME) for the operation and maintenance of utilities systems, offering technical expertise for 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 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 Specification Requirements (URS).
• Participate in system walk-downs to ensure reliable utility system operations.

Safety and Quality Compliance Management:

• Lead and support audit readiness for regulatory inspections to ensure compliance with site and global SOPs, GEP, and GDP.
• 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 Corrective and Preventive Actions (CAPA) are implemented to prevent recurrence.
• Lead and support change control and evaluation initiatives for continuous improvement, enhancing system reliability and operations.
• Actively promote and practice Amgen's Safety Culture.

Sustainability:

• Lead and support the site sustainability program, analyzing energy consumption data, benchmarking overall usage, and identifying opportunities for optimization.
• Lead and support the development of business cases to drive sustainability targets for the site.
• Generate utility consumption data for regulatory authority submissions.

Required Qualifications

• Diploma/Degree in Engineering, Mechanical, Electrical, Chemical
• Ability to work independently and collaboratively
• Good interpersonal and communication skills with high computer literacy
• Strong team player, able to effectively work within and across teams
• Fluency in communications skills, both oral and written, including presentation skills
• Familiar with documentation in a highly regulated environment
• Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
• Ability to tactfully negotiate and positively influence peers
• Strong analytical skills to identify potential improvement opportunities

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.

Skills Required