One of the world's foremost science and technology companies, Danaher is a global corporation that was founded in 1969 and has been developing, producing, and a
Senior Engineer, Process Validation
Location
United States
Posted
3 days ago
Salary
$100K - $130K / year
Seniority
Senior
Job Description
Senior Engineer, Process Validation
Danaher
Title: Senior Engineer, Process Validation Location:fully remote Job Description: 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 deliver world-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 Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND and will be fully remote. In this role, you will have the opportunity to: - Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach. - Lead the planning, execution, and lifecycle management of sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging and shipping. - Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including but not limited to process capability, trend analysis and control charts and DOE) interpretation. - Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events. - Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design The essential requirements of the job include: - Bachelor or master degree in engineering and 5+ years of experience - Prior experience in leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train using statistical analysis, risk assessment, and process improvement tools required. - Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices. - Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments. Travel, Motor Vehicle Record & Physical/Environment Requirements: - Ability to travel 15% to site to support validation project executions, routine inspections, audits, and client visits. It would be a plus if you also possess previous experience in: - Packaging and shipping validation of final product container closure configurations. - Client facing roles such as prior experience in a CDMO environment 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. At Aldevron we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Aldevron can provide. The annual salary range for this role is $100,000 to $130,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. #LI-PF1 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. 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.
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MFG ME CV AME ENG
Micron TechnologyMicron Technology specializes in memory and semiconductor technology, such as computer memory and image sensors. Since opening, Micron Technology has had a successful history and i
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ME エンジニアの職責• 期待する業務 -MXT Project Management -WorkstationのMaxOutを実行する。 -関係部門と連携して, Plan通りの安定したShip Out実施を目的として, 各BlockのWIP Balance Control及びConstant Operationに向けた生産管理活動を実施する。 -BKM 他, 生産• Control業務関連システムなどのglobal teamと連携をとり, 展開に際しサイトShift Team Memberに対して教育• 補佐• 継続的改善業務を担う。 -Output 最大化とCycle Time短縮の両方に責任を負う• 両立を追及する. -迅速なコンバージョンフローによるキャパシティ確保と検証時間短縮 -MASスケジューリング最適化に関して専門知識と, ロットスケジューリングを通じた生産効率の継続的改善を実施する。 MEチームにおけるエンジニアの責任と業務： -MXT Project Managementをリード -Maxoutプロジェクト対応で, スループット向上, CT（Cycle Time）短縮, WIPバランス制御を実施する。 -速なコンバージョンフローによるキャパシティ確保と検証時間短縮を実施する。 -MAS（Manufacturing Automation System）パラメータ調整によるロットスケジューリング改善を実施する。 -BKM（Best Known Method）展開と標準化を実施する。 -キャパシティモデルを用いた生産能力分析（Availability loss/Operation loss/Rate loss）• ボトルネック工程の特定と改善策立案を実施する。 -クロスファブ連携による改善活動（MCT/Sister Fabとの情報共有） を実施する。 -シフトチームへの教育• トレーニングを実施する。 望ましいSkill -キャパシティモデルを用いた生産能力分析業務経験 -MASを使った業務経験 -所属部署内外との協調• 交渉能力 -問題解析• 解決能力 -プロジェクト推進• 管理能力 -英語による筆記• 口頭 communication skills, TOEIC score > 600 -日本語による筆記• 口頭 communication skills, JLPT > = N1 or N2(MUST) -ビジネスレベルの英語と日本語 MFG ME ENGINEER ME Engineer Responsibilities and Expected Work - Management of MXT Project - Implement workstation MaxOut. - Work with relevant departments to implement production management activities aimed at WIP balance control and constant operation for each block, with the goal of achieving stable shipout according to plan. - Cooperate with global teams such as BKM and production/control-related systems, and provide training, assistance, and continuous improvement to site Shift Team Members during deployment. - Responsible for both maximizing output and reducing cycle time, striving for both. -Rapid conversion flow to secure capacity and reduce verification time - Have specialized knowledge of MAS scheduling optimization and implement continuous improvements to production efficiency through lot scheduling. ME Team Engineer Responsibilities and Work: - Lead the MXT Project -Implement MaxOut projects to improve throughput, reduce cycle time (CT), and control WIP balance. -Improve lot scheduling by adjusting MAS (Manufacturing Automation System) parameters. -Implement and standardize BKM (Best Known Method). -Conduct production capacity analysis (availability loss/operation loss/rate loss) using capacity models, identify bottleneck processes, and develop improvement plans. -Implement improvement activities through cross-fab collaboration (information sharing with MCT/Sister Fab). -Provide education and training to shift teams. Desired Skills -Experience using MAS -Ability to collaborate and negotiate within and outside the department -Ability to analyze and solve problems -Ability to promote and manage projects -Written and oral communication skills in English, TOEIC score > 600 -Written and oral communication skills in Japanese, JLPT >= N1 or N2(MUST) -Business-level English and Japanese About Micron Technology, Inc. We are an industry leader in innovative memory and storage solutions transforming how the world uses information to enrich life for all . With a relentless focus on our customers, technology leadership, and manufacturing and operational excellence, Micron delivers a rich portfolio of high-performance DRAM, NAND, and NOR memory and storage products through our Micron® and Crucial® brands. Every day, the innovations that our people create fuel the data economy, enabling advances in artificial intelligence and 5G applications that unleash opportunities - from the data center to the intelligent edge and across the client and mobile user experience. To learn more, please visit micron.com/careers All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. To request assistance with the application process and/or for reasonable accommodations, please contact hrsupport_japan@micron.com Micron Prohibits the use of child labor and complies with all applicable laws, rules, regulations, and other international and industry labor standards. Micron does not charge candidates any recruitment fees or unlawfully collect any other payment from candidates as consideration for their employment with Micron. AI alert: Candidates are encouraged to use AI tools to enhance their resume and/or application materials. However, all information provided must be accurate and reflect the candidate's true skills and experiences. Misuse of AI to fabricate or misrepresent qualifications will result in immediate disqualification. Fraud alert: Micron advises job seekers to be cautious of unsolicited job offers and to verify the authenticity of any communication claiming to be from Micron by checking the official Micron careers website in the About Micron Technology, Inc.
