Pall Biotech – Sr. Project Manager, Biotech PASS
Danaher, is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.5B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.
Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry. Pall Biotech provides cutting-edge solutions for customers who discover, develop and produce biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Our advanced medical technologies are often a patient’s last line of defence from dangerous pathogens. And our food and beverage products provide critical protection from contaminants during various manufacturing steps. Pall Corporation Head Quartered in New York US is the worldwide leader in filtration, separation and purification technologies to the Biopharmaceutical Industry. Pall Corporation has been partnering with customers for over 60 years helping them to solve their most critical and difficult fluid management challenges.
Pall today helps its customers to increase product quality, yields and efficiency, meeting regulations, remove barriers to innovation. Our commitment is to continuously enhance our ability to provide customers with the most effective Total Fluid Management SM solutions to help ensure their success. Pall Corporation has two business verticals: Life Science & Industrial.
In Life Sciences, our products are used from the earliest stages of discovery and development of drugs, through production and delivery of therapies for the prevention, diagnosis and treatment of diseases. Our unique capabilities come from a strong blend of Biopharmaceutical expertise, leading technologies and customer support. We provide reliable and fully integrated solutions for design, manufacture, sales and servicing of our disposable products as well as complex engineered systems and package units.
Pall Life Sciences handles all filtration, separation and purification applications from bulk preparation and synthesis to biological and biotech-based production of active ingredients, to downstream processing and formulation and final filling of products.
Pall Advanced Systems Solutions (PASS) is the unit of Pall Biotech, which is dedicated to consulting, construction and manufacturing of customized stainless steel and hybrid (Stainless Steel + Disposable) solutions for Bio-manufacturing. Pall has its PASS facilities world-wide. In Asia, Pall’s PASS facilities are located in China and India.
To support its customers in Life Sciences Markets, Pall’s PASS (Pall Advanced Separation Systems) facility in Pune, India has a dedicated group of Process Design & Project Managers who work closely with customers in Biotech, API, formulation & Fill.
The following types of systems are custom manufactured & almost all players in the Life Science markets are using Pall’s innovative solutions to meet their critical requirements.
UF- cross flow systems (based on cassette technology)
UF/MF- cross flow systems (based on hollow fiber technology)
MF- cross flow systems (based on VMF technology)
Automated virus removal systems
Automated filter test systems – Integrity systems
Fully automated separation and filtration processes (DSP) in plasma fractionation, biomass production and biotech/biopharmaceuticals.
Come join our winning team.
Analyse customer process user requirements specification for engineered process equipment (including different technologies such as direct flow filtration, tangential flow filtration, chromatography etc.) used in the Biopharmaceutical industry.
As technical lead of a project team discuss, propose, define final engineered technical system solution with the customer including writing technical part of quotation and associated costing. After Order placement execute the proposed engineered system solution based on agreed and defined contractual specification together with a defined project team as project manager or process engineer.
Make sure the projects are delivered in accordance to specification, on time and within budget.
Act as technical and managerial expert/coach and mentor within the team to develop the organization by coaching project managers and process engineers on their daily work and on critical technical questions which require specific knowledge and experience in this field
Take ownership of very complex technical tasks and issues.
Manage and Coordinated complex multi-unit operation solution projects
Pre-order Activities (Time Spent 20 %)
Analyze Customer User Requirements specifications
Define technical solutions including analysis of process mass balance, equipment selection and sizing, drafting process and instrumentation diagrams.
Write technical proposals including clarification and exclusion lists.
Create Project Costing sheets including material and manpower costs
Request, analyze and implement quotations for all main sub suppliers and include in technical proposal
Develop Project schedules
Perform Project Risk assessments
Present and discuss technical solution with customer
General PASS capability presentations
Co-ordinate Quote creation off complex systems projects
Co-ordinate Quote creation for multiple unit operation solution projects
Project Execution (Time Spent 55 %)
Contract review following customer order
SAP project creation and maintenance.
Develop Project Quality Plan
Complete basic design including process and instrumentation diagram, component lists and process functional specifications
Obtain valid quotations for all materials and initiate orders with procurement.
Cross functional communication, progress monitoring, coordination of sub supplier activities (e. g. mechanical fabricators, electrical Fabricators and software companies).#
Progress monitoring, reporting and control
Financial status monitoring, reporting and control
Coordination of incoming goods inspection
Percent of completion (POC) cost analysis and POC SAP data maintenance.
Execution and coordination of Qualification/Verification activities at the various project stages (pre-FAT, FAT, SAT, IV/OV)
Creation of technical documents and co-operate with Documentation team to assemble final technical documentation package.
Project Management and co-ordination of Small and mid-size projects.
Project Management and co-ordinate off complex systems projects
Project Management and co-ordinate for multiple unit operation solution projects
Review and approval of design, verification and project management documents
Coaching and Training (Time Spent 15 %)
On the job training for new team members
Execution of specific technical training topics
Mentoring and developing team members
Drive and Participate in Continuous improvement processes
Chair/Execute daily visual management
General Administration (Time Spent 10 %)
Skills/ Desired Characteristics
MSc/M. Tech or equivalent in Biotech, Biochemical engineering, Process engineering, chemical engineering or equivalent. A higher degree or secondary degree in a related subject would be an advantage
Minimum 7+ years of experience of process engineering / project management of downstream equipment used in Biopharmaceutical manufacturing including large scale and complex projects involving the integration of multiple systems.
Overall experience of 10 to 15 years
Proven track record of having lead and successfully executed various complex large-scale projects within the biopharmaceutical industry.
Experience in the design and engineering of process equipment for filtration, separation and purification equipment (direct or tangential flow, filtration, chromatography systems and columns etc.) used in a downstream & upstream process.
Experience of working on projects in various cultures.
Experience of working with outside subcontractors including mechanical fabricators, electronic fabricators, Software designers and automation experts.
Experience in qualification activities (FAT/SAT) for process equipment in the biopharmaceutical industry.
Ability and willingness to work in a multinational and interdisciplinary team with a high degree of travelling.
Ability to communicate effectively on complex technical / engineering issues at the highest level. Pall internal as well as with the customer.
Good communication skills in English language.
Knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment. (ASME BPE, GAMP, cGMP, ISPE, etc.)
Ability to teach other team members from professional experiences and detailed technical knowhow.
Leadership skills to lead a technical multi-disciplinary team.
To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures.