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 DescriptionThe 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.RequirementsKey ResponsibilitiesProject 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 operationCoordinating the introduction of new processes, equipment
and materials including problem solving and troubleshooting equipment issues
prior to qualification & start-upDevelopment 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 plansDevelopment and management of change controlsParticipate as a member of multidisciplinary site and
multisite teamsDevelopment of detailed specifications, engineering
documents, protocols and standard operating proceduresWork 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 proceduresSupport a safe working environment by complying with
environmental health/safety practice, rules and regulationsTravel may be required to support execution of projects Experience and Qualification:Bachelor’s degree in engineering (Mechanical, Electrical or
Chemical) or Relevant ExperienceTypically, 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 advantageousDemonstrated experience in a GDP Compliant environment.Experience in MS Office, MS Project, Change Control &
Document Management SystemsProven 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 resultsTechnical report writing and communication/presentation
skillsData driven decision makerAbility to work to tight deadlines in a fast-moving
environment#LI-BR1