Job Summary
We are seeking a highly skilled and strategic Operations Manager to oversee and optimize the day-to-day operational functions of our process engineering firm, with a strong focus on aseptic system design, integration, and implementation. This role is critical in ensuring that engineering projects are delivered efficiently, meet regulatory and client quality standards, and support the overall business objectives of safety, innovation, and performance.
Key Responsibilities
Operational Leadership
Manage and coordinate the daily operations of multiple aseptic engineering projects from design through commissioning.
Oversee cross-functional teams including engineering, procurement, project management, and field services.
Develop and maintain SOPs, KPIs, and operational benchmarks to ensure continuous improvement and process optimization.
Monitor resource utilization, supply chain logistics, and financial performance of projects to meet budgetary and scheduling goals.
Project Execution and Quality Control
Ensure all projects adhere to GMP, FDA, EU Annex 1, ISO 14644, and other regulatory requirements relevant to aseptic environments.
Collaborating with engineering leads to manage change controls, deviations, and validations for process systems (e.g., clean-in-place, steam-in-place, HVAC, isolators, sterilization tunnels).
Establish robust risk mitigation strategies for aseptic process-related failures or operational delays.
Client & Stakeholder Management
Serve as a key point of contact for clients regarding project status, deliverables, and issue resolution.
Translate customer needs into operational plans and align project execution with client expectations.
Foster long-term client relationships by ensuring operational excellence and responsiveness.
Team Development & Leadership
Lead, mentor, and develop a high-performing operations team, cultivating a culture of safety, accountability, and innovation.
Promote interdisciplinary collaboration and support professional growth of team members.
Qualifications
Education & Experience
Bachelor’s degree in engineering, Industrial Management, or a related technical field (master’s preferred).
Minimum 7–10 years of operations or project management experience in process engineering, with at least 3 years in aseptic/cleanroom environments.
Proven experience managing capital projects and commissioning aseptic systems in pharmaceutical, biotech, or advanced food manufacturing.
Skills & Competencies
Deep understanding of aseptic processing principles, contamination control, and cleanroom classifications.
Strong knowledge of engineering documentation, URS, FDS, FAT/SAT, IQ/OQ/PQ protocols.
Exceptional leadership, communication, and interpersonal skills.
Proficient in project management tools (MS Project, Primavera, or similar) and ERP/MRP systems.
Six Sigma, Lean, or PMP certification is a strong advantage.
