Process Engineer II

Posted Yesterday
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Pune, Mahārāshtra
In-Office
Senior level
Biotech
The Role
Manage process engineering enquiries and project execution for USP & DSP biopharma systems: URS review, costing, P&ID, DQ documentation, qualification protocols, FAT/SAT activities, SAP OTD management, internal audits, and team training under Danaher Business System.
Summary Generated by Built In

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Project Manager for Cytiva is responsible for managing project enquiries and Process Engineering design and lead project management at CE at India, APAC region for customized Engineering and standard systems for USP & DSP portfolio in Biopharma and Pharma Industry.

This position is part of the PEPM (Process Engg, Project Management) located in Pune and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Enquiry management in terms of customer discussions, URS Review & Compliance Prep, Technical Proposal, Costing, P & ID Prep, supporting pre-sales etc.>
  • Mass Balance prep, list of equipment prep, costing, Presales support for end to end solutions.
  • Preparation of DQ1 & DQ2 docs in ref to Process engineering design, Project management, Cross functional communication, customer management, OTD in terms of project milestones, SAP OTD management and handover.
  • Preparation of qualification protocols and Executing SFAT, Mechanical inspection, PreFAT, FAT, SAT, Customer feedback reports and follow all the procedures as mentioned in the project realization chart. 
  • Conducting Internal Audits for following of internal procedures and learn and implement DBS related activities for improvements and train the team with industrial experience. 

Who you are:

  • Masters degree in Biotech or related fields with Biotech projects execution experience greater than 4 years.
  • Acquaintance with various Biotech USP / DSP equipment sizing and risk assessment approach doc prep
  • Lead plant setup, utilities calculations, equipment positioning and optimizing processes for higher yields

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Top Skills

Danaher Business System (Dbs)
P&Id
SAP
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The Company
HQ: Sunnyvale, CA
4,883 Employees
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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