Senior HVAC Engineer

3 weeks ago

Dublin, Ireland PSC Biotech Ltd Full time
Job Description

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Senior HVAC Engineer

 

Job Description:

 

The Senior HVAC Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Labelling and Packaging areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.



Requirements

Key Responsibilities:

•           Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.

•           Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operation.

•           Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up

•           Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.

•           Ability to translate strategic/emerging technology solutions into pragmatic executable plans.

•           Development and management of change controls

•           Participate as a member of multidisciplinary site and multisite teams.

•           Development of detailed specifications, engineering documents, protocols, and standard operating procedures

•           Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.

•           Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers, and Vendors to perform equipment upgrade and/or retrofits.

•           Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.

•           Support a safe working environment by complying with environmental health/safety practice, rules and regulations.

•           Travel may be required to support execution of projects.

 

Experience and Qualification:

•           Bachelor’s degree in engineering (Mechanical, Electrical or Chemical) or Relevant Experience

•           Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes.

•           Proven project management experience.

•           Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous.

•           Demonstrated experience in a GDP Compliant environment.

•           Experience in MS Office, MS Project, Change Control & Document Management Systems

•           Proven ability working cross functionally, delivering technical solutions, and implementing improvements.

•           Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results.

•           Technical report writing and communication/presentation skills.

•           Data driven decision maker.

•           Ability to work to tight deadlines in a fast-moving environment.



#LI-BR1

Requirements
Responsibilities include: The chosen candidate would typically be accountable for the following activities (but not exclusively): • Lead for Root Cause Assessments, investigations, deviations for any operational issues related to the Systems owned throughout the lifecycle to delivery to end-user. • Liaison with CQV and QA on execution of FATs, SATs, IOQ and PQ protocols and with EHS on Safety and Environmental issues • Being the site contact (SME Subject Matter Expert) for all aspects of the delivered HVAC equipment, within the works of new equipment install boundary. This includes balancing, certification and recertification, stability, exhausting of VHP cycles and all airflow performance aspects of the source AHUs and Isolator envelope. • Rolling out training on systems for which the candidate is the designated SME / System Owner • Data trend analysis of all performance aspects of their systems and equipment to identify and proactively manage performance trends, including anticipating, solving or escalating problems as appropriate. • Troubleshooting of performance trends. • Risk assessments and mitigation projects relating to system performance. • Ensuring the preventative maintenance schedule for their systems is successfully setup on Site CMMS system. • Ensuring that critical spare parts lists for their system are identified and appropriate levels of spares are maintained. • All design reviews associated with equipment purchases / changes to their systems. • The development and execution of FAT, SAT and IOQ protocols along with other Team members • Reviewing and approval of changes to operating procedures related to the introduction of their systems on site. Basic Qualifications: • Bachelor’s degree in engineering (Mechanical, Electrical, Chemical) • Expert in the design, sizing, testing & balancing, installation, commissioning of HVAC and Isolator HVAC systems preferably in the Pharmaceutical or Biotechnology industries. • Experience in the Pharmaceutical or Biotechnology industries preferable. #LI-BR1

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