Operations Engineer

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 You will support the startup and operational readiness of buffer/media and material preparation areas as part of a brownfield facility expansion project. The role focuses on ensuring operational requirements are met through equipment onboarding, process readiness, and cross-functional coordination, ultimately supporting the transition to GMP manufacturing. Key Responsibilities Support startup activities for buffer/media and raw material preparation areas, including equipment verification, commissioning, and handover. Lead protocol writing, execution, review, and coordination of validation activities. Participate in process and layout design reviews, ensuring alignment with manufacturing operational needs. Work collaboratively with Engineering, Manufacturing, Quality Assurance, and CQV teams to ensure readiness for GMP operations. Assist in the development, review, and implementation of operational documentation, including SOPs, batch records, and work instructions. Coordinate mock runs, operator training, and readiness assessments to support go-live milestones. Provide support for material movement, staging, and flow strategies within cleanroom environments, ensuring compliance with GMP standards. Facilitate issue resolution during equipment startup and process simulations, escalating as needed. Promote safe working practices and ensure adherence to EH&S and GMP regulations during all activities. Required Qualifications Bachelor's Degree in Engineering, Life Sciences, or related discipline from a recognized institution. 3-7 years of relevant experience in pharmaceutical, biopharmaceutical, or related manufacturing environments. Experience with buffer/media preparation processes and raw material handling. Well-versed in equipment, process, cleaning, and computer system validation (CSV). Prior involvement in facility startup or brownfield/greenfield expansion projects is preferred. Knowledge of GMP regulations and cleanroom operations is required. Able to work collaboratively with cross-functional teams and external vendors. Strong written and verbal communication skills 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 teamPlease submit your resume, outlining your qualifications and experience relevant to the role, here. #J-18808-Ljbffr