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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.
Job Description :
The Senior HVAC Engineer reports to the Senior Manager forStrategic Engineering Projects and is responsible for scoping and executingtechnical projects supporting Drug Product manufacturing within Formulation,Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly,Inspection, Labelling and Packaging areas. This includes qualification of newequipment and implementation of associated reliability and maintenanceprograms.
Key Responsibilities:
• Project management and execution of assignedprojects including project prioritization, resources management, statusmanagement and external communication.
• Working with various stakeholders, to scopeprojects and ensure requirements are satisfied. Project input will span fromconcept, through design, construction, commissioning and operation.
• Coordinating the introduction of new processes,equipment and materials including problem solving and troubleshooting equipmentissues prior to qualification & start-up
• Development and implementation of maintenanceprograms and spare parts inventory optimization with the introduction of newequipment.
• Ability to translate strategic/emergingtechnology solutions into pragmatic executable plans.
• Development and management of change controls
• Participate as a member of multidisciplinarysite and multisite teams.
• Development of detailed specifications,engineering documents, protocols, and standard operating procedures
• Work in a collaborative manner within theProcess Teams structure and contributes to Root Cause Investigations and CrossFunctional Investigations.
• Works in a collaborative manner with the SystemOwners, Maintenance Supervisors & Technicians, Capital Project Engineers,and Vendors to perform equipment upgrade and/or retrofits.
• Perform all tasks with due care and attentionensuring compliance with Good Manufacturing Practices and company requirements,policies and procedures.
• Support a safe working environment by complyingwith 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 environmentor Automated Inspection and/or Automated Device Assembly, Labelling andAncillary processes.
• Strong mechanical capability with hands onexperience in a technical role within a high-volume manufacturing environment,is advantageous.
• Demonstrated experience in a GDP Compliantenvironment.
• Experience in MS Office, MS Project, ChangeControl & Document Management Systems
• Proven ability working cross functionally,delivering technical solutions, and implementing improvements.
• Solid leadership skillset and experience workingin a team environment, embracing an interdependent working culture thatdelivers results.
• Technical report writing andcommunication/presentation skills.
• Ability to work to tight deadlines in afast-moving environment.
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