Senior Project Engineer

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. Job Description The Project / Equipment Engineer reports to the Senior Manager for Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling and Lyophilisation. 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 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