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Danaher Corporation Principle Engineer – Automation, Instrumentation & Commissioning in Maharashtra, India

Pall Biotech – Principal Engineer Automation

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.

  • Chromatography systems

  • 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.

Position Objective:

The Principal Engineer for Automation is responsible for developing, customizing, and sustaining of hardware and software for the biotech industry and market. This position will lead developments from conception - managing specification, design, industrialization, and transfer to manufacturing as part of a global multi-disciplinary software development. As a Principal Engineer, you will be required to work with in the accepted industry standards whilst pursing innovative solutions to enable novel products to be released with the expected quality levels. This position is responsible for Instrumentation, Control & automation related all activities of Biopharm systems wherever installed in India & South-East Asia.

Responsibilities:

Job description

  • Serve as the architect of our control systems, automation and electrical design, identifying and selecting

relevant components with their communication protocols (sensors, actuators, controllers, etc.) and

supplier’s necessary for the realization of prototypes and products.

  • Partner with internal and external automation vendors to obtain new hardware, develop new prototype

    hardware elements, build interfaces, and integrate hardware into the automation platform.

  • Responsible for automation life cycle management activities including change management,

root cause investigations, and tracking and prioritization of feature requests, bug reports,

component obsolescence, etc.

  • Collaborate with product development teams and customers to deliver state of the art automation

systems for bioprocessing systems.

  • Lead technical solution design and the high-level alignment of business goals with technical projects.

  • Effectively communicate and present project status to internal and external project team

members and stakeholders.

  • Support Voice of Customer activities during the New Product Development process.

  • Foster innovation and actively contribute to innovation database.

  • Define validation protocols and testing regimes. Assemble and test controller prototypes and

    perform modifications.

  • Perform simulation testing of software independently with software supplier and must manage

commissioning activities in FAT & SAT related to software & system operations

  • Perform trouble shooting and maintenance on-site at customers for newly developed and/or

    launched products (before passing G6).

  • Responsible for preparation of technical documentation of products and of the systems

(electrical drawings, FDS/SDS/HDS/IOL/FAT/IQ/OQ).

  • Directing electrical team & designers/Draftsman for electrical line diagram for instruments, drives & PLC and associated cards

  • Listen, understand, translate internal and external customers’ requirements.

  • Write procedures, documentation and reports related to tests and tasks performed.

  • Serve as an expert on your field/products and challenge the technical concepts of your colleagues.

  • Supports bringing the global automation strategy to practice.

  • Champions Danaher Business System tools relevant to software development

  • Manage applicable regulatory requirements of automation and control systems.

  • Other duties as assigned.

Skills/ Desired Characteristics

  • BE Instrumentation or automation engineering. A higher degree or secondary degree in a related subject would be an advantage

  • Minimum 10-15+ years of experience in automation and must be associated with Biotech Industry

Position Competencies

  • Ability and willingness to work in a multinational and interdisciplinary team

  • Candidate shall be both motivated and committed to producing high quality work according to schedules and timelines.

  • Ability to work as an integral part of a multifunctional customer focused team will be critical. Excellent communication and interpersonal skills are a must.

  • Basic Knowledge of Unit operation, process & filtration

  • Candidate must have knowledge of GAMP, S88 standards, 21 CFR Part 11 & software current guidelines applicable for manufacturing Biopharmaceutical machineries

  • Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

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