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The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron's Fargo, ND site. In this role, you will have the opportunity to: Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product.

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Aldevron, 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.At Aldevron, we deliverworld-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you'll help bring life-changing innovations to life-impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential-one discovery at a time.Learn about the Danaher Business System ( which makes everything possible.The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron's Fargo, ND site. As the subject matter expert in validation, this position leads the development, execution, and implementation of validation, practices, policy, and procedures.This position reports to the VP, Global Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role.In this role, you will have the opportunity to:<ul><li>Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product</li><li>Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design</li><li>Develop and implement validation policies and procedures based on current regulations and industry standards</li><li>Provide subject matter expertise during client and regulatory audits, kaizen and workshop events, and manufacturing support</li><li>Help resolve quality issues and CAPA's leading lab investigations, risk assessments, root cause analysis, and developing implementation plans</li></ul>The essential requirements of the job include:<ul><li>Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) with 5+ years of experience or MS degree with 3+ years of experience.</li><li>PhD in Engineering or Scientific field with 2+ years of experience.</li><li>Experience in process development, engineering, and process validation required. Experience working in CDMO environment is a plus</li><li>Experience using statistical, risk assessment, and process improvement tools</li></ul>Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role<ul><li>10% travel to support routine inspections, audits, and customer projects</li></ul>It would be a plus if you also possess previous experience in:<ul><li>Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines</li></ul>Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .#LI-KP1Join 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.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.The U.S. EEO posters are available here ( .For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here ( .We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.

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 applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Danaher Corporation

Sr. Validation Engineer, Process Validation

Biology

Biotech and Pharmaceutical

Business Solutions

Continuous Improvement

Corrective and Preventative Action (CAPA) Systems

Current Good Manufacturing Practice (cGMP)

Drug Products

Environmental Regulations

Genomic Medicine

Industry Standards

Manufacturing

Mentoring

Microbiology

Policy Implementation

Problem Solving Skills

Procedure Implementation

Process Development

Process Improvement

Process Validation

Regulations

Risk Analysis

Root Cause Analysis

Statistics

Support Documentation

Team Player

Technical Operations

Validation Documentation

Willing to Travel

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In this position, you will be the main point of contact for planning and design of water, water reuse, and wastewater projects and will assist with business development activities throughout the U.S. CDM Smith's Industrial Business unit services clients in a variety of industrial sectors including; High Tech, Data Centers, Chemicals, Rubber & Plastics, Petrochemical, Oil & Gas, Food & Beverage, Mining and Manufacturing. In addition, during employment individuals may be required by CDM Smith or a CDM Smith client to successfully complete additional background checks, including motor vehicle record as well as drug testing.

44563BRRequisition ID:44563BRBusiness Unit:INDJob Description:CDM Smith currently has a new opportunity for a Senior Project Manager with previous experience managing industrial water and/or wastewater projects to join our Industrial Business unit. In this position, you will be the main point of contact for planning and design of water, water reuse, and wastewater projects and will assist with business development activities throughout the U.S. CDM Smith's Industrial Business unit services clients in a variety of industrial sectors including; High Tech, Data Centers, Chemicals, Rubber & Plastics, Petrochemical, Oil & Gas, Food & Beverage, Mining and Manufacturing.*** This position is hybrid with a minimum of two days in the office and can be based at any of our Industrial offices in the United States. Some of those cities include Houston, Irvine, Fairfax VA, Portland, New Orleans, Raleigh, Atlanta, Chicago, Phoenix, Austin, Concord CA, Edison, Albany, Boston, and Wadsworth, OH ***As a member of this team, you would contribute to CDM Smith's mission by:• Managing and serving as the lead Project Manager on water/wastewater projects• Providing technical guidance, senior leadership, and mentoring engineering staff to enhance our water/wastewater design capabilities• Being responsible for scope, schedule, budget development, monitoring and adherence for projects managed• Completing Quality Assurance/Quality Control of key deliverables and assisting on projects managed by others in the office• Assisting Client Service Leaders with technical marketing for clients throughout the U.S.• Participating in professional societies relevant to the industry.• Building and maintaining positive working relationshipswith key decision makers in our clients' organizationsJob Title:Industrial Water/Wastewater Project ManagerGroup:INDEmployment Type:RegularMinimum Qualifications:• Bachelor's Degree• 10 years of related experience• PMP (PMI), CCM or DBIA certification is required (within 12 months of hire or promotion onto the Approved Project Manager list)• Domestic and/or international travel may be required. The frequency of travel is contingent on specific duties, responsibilities, and the essential functions of the position, which may vary depending on workload and project demandsEquivalent additional directly related experience will be considered in lieu of a degree.Preferred Qualifications:• Professional engineering (PE) license, strongly preferred.• Bachelor's degree in civil, environmental, or chemical engineering, or related degree.• Previous experience working on and managing projects for Industrial water/water reuse/wastewater clients.• Previous experience managing multi-discipline project teams.• Excellent communication, networking and team building skills.• Previous experience working directly with clients• Master's degree.• Previous business development experience including preparation of proposals and scopes of work and costs estimates for industrial clientsEEO Statement:We attract the best people in the industry, supporting their efforts to learn and grow. We strive to create a challenging and progressive work environment. We provide career opportunities that span a variety of disciplines and geographic locations, with projects that our employees plan, design, build and operate as diverse as the needs of our clients. CDM Smith is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, pregnancy related conditions, childbirth and related medical conditions, sexual orientation, gender identity or gender expression), national origin, age, marital status, disability, veteran status, citizenship status, genetic information or any other characteristic protected by applicable law.Why CDM Smith?:Check out this video and find out why our team loves to work here! (Join Us! CDM Smith – where amazing career journeys unfold.Imagine a place committed to offering an unmatched employee experience. Where you work on projects that are meaningful to you. Where you play an active part in shaping your career journey. Where your co-workers are invested in you and your success. Where you are encouraged and supported to do your very best and given the tools and resources to do so. Where it's a priority that the company takes good care of you and your family.Our employees are the heart of our company. As an employer of choice, our goal is to provide a challenging, progressive and inclusive work environment which fosters personal leadership, career growth and development for every employee. We value passionate individuals who challenge the norm, deliver world-class solutions and bring diverse perspectives. Join our team, and together we will make a difference and change the world.Job Site Location:United States - NationwideAgency Disclaimer:All vendors must have a signed CDM Smith Placement Agreement from the CDM Smith Recruitment Center Manager to receive payment for your placement. Verbal or written commitments from any other member of the CDM Smith staff will not be considered binding terms. All unsolicited resumes sent to CDM Smith and any resume submitted to any employee outside of CDM Smith Recruiting Center Team (RCT) will be considered property of CDM Smith. CDM Smith will not be held liable to pay a placement fee.Amount of Travel Required:10%Assignment Category:Fulltime-RegularVisa Sponsorship Available:No - We will not support sponsorship, i.e. H-1B or TN Visas for this positionBackground Check and Drug Testing Information:CDM Smith Inc. and its divisions and subsidiaries (hereafter collectively referred to as “CDM Smith”) reserves the right to require background checks including criminal, employment, education, licensure, etc. as well as credit and motor vehicle when applicable for certain positions. In addition, CDM Smith may conduct drug testing for designated positions. Background checks are conducted after an offer of employment has been made in the United States. The timing of when background checks will be conducted on candidates for positions outside the United States will vary based on country statutory law but in no case, will the background check precede an interview. CDM Smith will conduct interviews of qualified individuals prior to requesting a criminal background check, and no job application submitted prior to such interview shall inquire into an applicant's criminal history. If this position is subject to a background check for any convictions related to its responsibilities and requirements, employment will be contingent upon successful completion of a background investigation including criminal history. Criminal history will not automatically disqualify a candidate. In addition, during employment individuals may be required by CDM Smith or a CDM Smith client to successfully complete additional background checks, including motor vehicle record as well as drug testing.Pay Range Minimum:$120,973Pay Range Maximum:$211,723Additional Compensation:All bonuses at CDM Smith are discretionary and may or may not apply to this position.Work Location Options:Hybrid Work Options may be considered for successful candidate.Massachusetts Applicants:It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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Sr. Validation Engineer, Process Validation Danaher Corporation

Industrial Water/Wastewater Project Manager CDM Smith

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