Bechtel—Pharma SME - Process

Job description

Description: Requisition ID: 299321 - Relocation Authorized: None - Telework Type: Full-Time Office/Project - Work Location: Chennai Extraordinary teams building inspiring projects: Since 1898, we have helped customers complete more than 25,000 projects in 160 countries on all seven continents that have created jobs, grown economies, improved the resiliency of the world's infrastructure, increased access to energy, resources, and vital services, and made the world a safer, cleaner place. Differentiated by the quality of our people and our relentless drive to deliver the most successful outcomes, we align our capabilities to our customers' objectives to create a lasting positive impact. We serve the Infrastructure; Nuclear, Security & Environmental; Energy; Mining & Metals, and the Manufacturing and Technology markets. Our services span from initial planning and investment, through start-up and operations. Core to Bechtel is our Vision, Values and Commitments. They are what we believe, what customers can expect, and how we deliver. Learn more about our extraordinary teams building inspiring projects in our Impact Report. Bechtel’s India offices support the execution of projects and services around the world. Working seamlessly with Bechtel’s global business units, project sites, customers, and suppliers, our teams have delivered more than 125 projects since 1994. With offices in Gurgaon, Vadodara, and Chennai there are exciting career opportunities for candidates who are passionate about delivering projects that make a lasting, meaningful difference for people and communities around the world. Job Summary: In this role, you will conduct field investigations and special studies for process/chemical design for large projects. You will lead the design, development, modification, and evaluation of components and processes used in process/chemical for projects with unique requirements. Your coordination will ensure that complex technical issues are resolved, clients are satisfied, and project needs are met. Major Responsibilities: - Plans, schedules, conducts, and coordinates process work for a global business unit delivering projects in Pharmaceutical Industry. Performs work that involves conventional engineering practice but may include solving complex design issues. Ability to support multiple projects as a subject matter expert. - Review and provide design recommendations for new projects and proposed facility modifications to ensure conformance with relevant codes, standards and procedures. - Assists in on-the-job training of assigned personnel and provides input for their performance evaluations. - Prepares or assists in preparation of conceptual studies, designs, reports or proposals. - Prepares and/or assists in the preparation of cost estimates, quantity take-offs and staffing requirements for proposals, forecasts and change orders. - Reviews and checks work of subordinate engineers. - Co-ordination with internal teams for the process related inputs / outputs. - Plans and coordinates process deliverables for pharmaceutical projects ensuring compliance with code requirements. - Supports the creation of a work environment that fosters openness, trust, communication, teamwork, empowerment, innovation, and satisfaction. - Candidates should be able to demonstrate successful delivery of projects requiring strict regulatory compliance and detailed documentation control. Education and Experience Requirements: - 15+ years of relevant life sciences experience - Experience on large capital projects - Experience supporting GMP facility startup activities - Experience in fast-track projects - Experience with EPC, EPCM, Owner's Representative, or Contractor environments Candidates should demonstrate the ability to work effectively with Owners, Engineering teams, Operations, Quality organizations, CQV organizations, Validation teams, Construction teams, Vendors and Regulatory representatives. The ability to coordinate multidisciplinary teams in regulated environments should be considered a core competency. Candidates should also demonstrate experience with: - Pharmaceutical process design - API manufacturing processes - Bioprocessing systems - Process risk assessments - Process flow diagrams (PFDs) - P&IDs - Process safety integration - Process qualification support - GMP facility startup support Preferred experience: - Process characterization - Technology transfer - Manufacturing process validation - Cleaning validation awareness Required Knowledge and Skills: Candidates should demonstrate experience supporting one or more of the following: - Bulk API manufacturing facilities - Oligonucleotide manufacturing facilities - Sterile manufacturing facilities - Biopharmaceutical manufacturing - Secondary packaging facilities - GMP laboratories - QC and analytical laboratories - Warehouse and cold-chain facilities supporting GMP operations - Validated utility systems and infrastructure serving GMP facilities Experience in regulated pharmaceutical, biotechnology, medical device, laboratory, healthcare, or life sciences environments are preferred. Preferred Pharma candidates should possess a practical understanding of: - Current Good Manufacturing Practice (cGMP) - FDA 21 CFR Parts 210 and 211 - Good Documentation Practices (GDP) - Change control processes - Deviation management - Risk-based quality management - Inspection readiness - Regulatory compliance expectations Total Rewards/Benefits: For decades, Bechtel has worked to inspire the next generation of employees and beyond! Because our teams face some of the world's toughest challenges, we offer robust benefits to ensure our people thrive. Whether it is advancing careers, delivering programs to enhance our culture, or providing time to recharge, Bechtel has the benefits to build a legacy of sustainable growth. Learn more at Bechtel Total Rewards Diverse teams build the extraordinary: As a global company, Bechtel has long been home to a vibrant multitude of nationalities, cultures, ethnicities, and life experiences. This diversity has made us a more trusted partner, more effective problem solvers and innovators, and a more attractive destination for leading talent. We are committed to being a company where every colleague feels that they belong-where colleagues feel part of "One Team," respected and rewarded for what they bring, supported in pursuing their goals, invested in our values and purpose, and treated equitably. Click here to learn more about the people who power our legacy. Bechtel is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, disability, citizenship status (except as authorized by law), protected veteran status, genetic information, and any other characteristic protected by federal, state or local law. Applicants with a disability, who require a reasonable accommodation for any part of the application or hiring process, may e-mail their request to acesstmt@bechtel.com Skills: process design, gmp compliance, api manufacturing, bioprocessing, process risk assessment, p&id, process safety integration, process qualification support, epc, epcm, owner's representative, contractor management, change control, deviation management, risk-based quality management, inspection readiness, regulatory compliance, fda 21 cfr parts 210 and 211, good documentation practices, process characterization, technology transfer, manufacturing process validation, warehouse and cold-chain facilities, sterile manufacturing, oligonucleotide manufacturing, secondary packaging facilities, gmp laboratories, qc and analytical laboratories