Job Description (J D) for Domain Expert - Pharma HVAC, Utility Systems & Process Engineering

Position Overview: 

- The Domain Expert in Pharma HVAC & Utility Systems will supervise and manage the design, implementation, and optimization of HVAC systems and utilities. In addition to making sure that all systems meet operational and environmental requirements and regulatory standards and contribute to the safe and effective production of pharmaceutical products, the role entails overseeing the design, optimization, and validation of pharmaceutical manufacturing processes by the domain expert in pharma process engineering. 

- This position involves ensuring that all procedures adhere to legal requirements, maximize productivity, and uphold the highest standards of product quality. To make sure that process engineering solutions complement the overarching objectives of the pharmaceutical operation, the expert will collaborate closely with cross-functional teams. In pharmaceutical production environments,

Key Responsibilities:

Process design and optimization as well as system design and implementation:

- To ensure compliance with cGMP, FDA, and ICH Guidelines and other Pertinent standards oversee the design, specification, and implementation of HVAC and utility systems.

- Work together with engineering teams to create comprehensive blueprints for HVAC systems, encompassing ducting, filtration systems, air handling units (AHUs), and chillers.

- Oversee the formulation, mixing, granulation, coating, and packaging procedures involved in pharmaceutical manufacturing process design and optimization.

- Create comprehensive process descriptions, process and instrumentation diagrams (P&IDs), and process flow diagrams (PFDs).

Process Validation & Regulatory Compliance:

- Verify that all utility and HVAC systems adhere to legal specifications, including ISO cleanroom classifications, environmental controls, and documentation procedures.

- Assist with validation tasks, such as Performance Qualification (PQ), Operational Qualification (OQ), and Installation Qualification (IQ).

- Make sure that all process engineering endeavors adhere to regulatory guidelines, such as those established by the FDA, EMA, and other pertinent organizations.

- Oversee validation tasks such as process design, ongoing process verification (CPV), and qualification (IQ/OQ/PQ).

- Analyse process data to identify trends, optimize parameters, and ensure consistent product quality.

Maintenance, Continuous Improvement, and System Optimization:

- To sustainability and energy efficiency, monitor and improve HVAC system performance.

- Investigate and fix problems with HVAC systems to minimize production disruption.

- Determine prospects for ongoing enhancement in production procedures to augment effectiveness, curtail expenses, and elevate the Caliber of the final product.

- Oversee cross-functional teams in the identification and execution of remedial measures for process deviations.

Project Management and Technology Transfer:

- Lead and manage HVAC and utility-related projects from concept to completion, ensuring timely delivery within budget and documenting and standardizing processes for efficient and reproducible production.

- Coordinate with cross-functional teams, including facilities, manufacturing, quality, and safety departments, to ensure project alignment with overall business objectives.

- Prepare and present project reports, including progress updates, risk assessments, and budget forecasts.

- Collaborate with R&D, quality assurance, and manufacturing teams to ensure that new processes are scalable, robust, and meet quality standards.

Training, Development, and Mentorship:

- Provide training and support to the operations and maintenance teams on HVAC system operation, troubleshooting, and best practices.

- Stay updated on the latest technologies, industry trends, and regulatory changes affecting pharmaceutical HVAC and utility systems.

- Develop and deliver training programs on new processes, equipment, and technologies.

Qualifications:

- Bachelor's degree in mechanical engineering, Chemical Engineering, or a related field; a Master's degree is a plus.

- At least 14-20 years of experience in HVAC and utility systems within the pharmaceutical or biotechnology industry.

- Extensive knowledge of regulatory requirements, including cGMP, FDA, ISO 14644, and other industry standards.

- Proven experience in designing, implementing, and validating HVAC systems in cleanroom environments.

- A minimum of 10-14 years of experience in pharmaceutical process engineering, with a strong background in process design, validation, and optimization.

- Proven experience in process validation, including IQ, OQ, PQ, and CPV.

- Experience in technology transfer and scaling processes from R&D to full-scale production.

Skills:

- Knowledge of utility systems, such as compressed air, steam generation, and water purification, as well as proficiency in HVAC system design, including load estimates, air distribution, and filtration.

- Possess expertise with pertinent software tools, including HVAC simulation software, AutoCAD, and Revit.

- Excellent interpersonal and communication skills, capable of working well in cross-functional teams and Outstanding abilities in managing many projects concurrently.

- Meticulous and meticulous, having a primary emphasis on compliance and quality.