About PSC Biotech
Who are we?
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.
Summary:
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The role involves utilizing project management best practices for the effective and efficient development of savings type projects on the Value Capture Program.
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The incumbent will also utilize Engineering principles and Lean problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision of site goals on reducing Scrap, Consumables usage, Direct Labour wastage. He/she will be tasked at the identify, scope, design and lead several projects.
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12 Month of contract role
Responsibilities:
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Team member representing the End 2 End Engineering function supporting projects with a focus on Quality, Savings, Capacity, Validation type projects used in the manufacturing processes across the entire Orthopaedic Range of Products
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Prepare several documents on the projects & dash; scoping, designing, implementation & execution
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Support colleagues to complete several project related tasks
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Responsible for identifying savings on site linked to Direct Labour in-efficiencies, Scrap, Consumables spend.
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Ensuring new or amended manufacturing process improvements are aligned with operation's needs, quality, EHS, validation, finance, automation, maintenance requirements, seeking collaboration and funding for the project with Senior Leaders.
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Presentation to Senior Management Weekly on Status or need for funding
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Determine operations & process inputs and outputs ranges of machine prior to commencing validation
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Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ, OQ, PQ) of assets and associated machines.
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Partner with Quality, Operations, CSV and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design Communicate effectively with project manager and other managers, global functions and internal team on status of project (s) tasks, issues and requirements.
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Provide timely and accurate reporting and management of escalations as appropriate on project activities.
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Ensure all activities comply with GMP, ISO and quality system requirements.
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Ensure that all health, safety and environmental requirements are fulfilled.
Education & Experience Required:
Essential:
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MSc in Engineering or Science with > 7 years’ experience in a medium to high volume manufacturing environment – Food Processing, Paint Industry, Oil & Gas, Orthopedics
2 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
Work from the office to hands on with fellow Engineer’s development of trials, experiments, development of projects.
Desirable:
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Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
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A thorough understanding of GMP/ISO and validation regulations.
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Technical training Six Sigma/Black Belt/Lean Manufacturing experience projects using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
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Problem solving engineering expertise (Six Sigma, SE or A3)
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Understanding of the Mechanical Engineering process and Process Validation expertise is preferred
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Strong verbal and written communication skills
Reports To: Project Leader
