Process Engineer, MSAT Contractor
3 weeks ago
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:As a Process Engineer (Contractor) in Manufacturing Science and Technology, you will provide technical support for GMP manufacturing, technology transfers, validation, and continuous improvement projects within a highly matrixed cross functional team for Base Camp programs. As part of support, you will write protocols, product impact assessments, root-cause analysis reports, sampling plans, technical reports. You will support data collection and charting for non-GMP and GMP batches.This is a 4-month contract.Here's What You'll Do:Working cross-functionally across Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide support for technology transfers and process changes in a cGMP environment.Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.Assist in the root cause determined of process related deviations in a timely and conclusion manner. The Candidate will work with a cross functional team to resolve complex problems and deviations using experience and the efficient application of scientific methodology and technical reasoning.Support gap analyses and risk assessments to support the capital projects and tech transfers.Assist in execution of Process Validation activities or other site initiatives including authoring protocols and reports.Assist in development of data-based process performance monitoring systems.Perform process data-driven deviation resolution and improvement projects.Requirements:BS/MS/PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+/3+/1+ years of relevant experienceDemonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture. Op with cGMP manufacturing and regulatory regulations and requirements.Drug manufacturing experience required. Use of LOVO, Sepax, Rotea, CliniMACs devices, automated fillers preferred.Experienced with leading investigations, writing, deviation reports, change controls, and corrective actionsAbility to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilitiesExperience working in cross functional teams to obtain project deliverablesKnowledge of data management tools and statistical process controlsWhy Join ElevateBio?ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.Our Mission: To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.Our Vision: We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
-
Pharmaceutical Process Development Engineer
2 weeks ago
Watertown, Massachusetts, United States Collabera Full timeAbout This RoleWe are seeking an experienced Pharmaceutical Process Development Engineer to join our team at Collabera. As a key member of our operations, you will play a crucial role in the development and implementation of efficient manufacturing processes.
-
Watertown, New York, United States MRG Exams Full time**About Us**MRG Exams is a leading provider of Independent Medical Exams, serving the nation's veterans with disability assessments. Our team is dedicated to helping military families achieve work-life balance while making a difference in their lives.**Job Overview**We are seeking an experienced Licensed Psychologist to join our team as an Independent...
-
Process Engineering PM
4 weeks ago
Watertown, MA, United States Arcadis Full timeAbout The JobArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s...
-
Watertown, Massachusetts, United States Dragonfly Therapeutics, Inc. Full timeJob SummaryWe are seeking a skilled Downstream Process Development Engineer to join our Tech Ops team. The successful candidate will play a key role in collaborating with the R&D and Tech Ops teams to develop, optimize, and integrate cutting-edge processes and technologies for biologics process development.ResponsibilitiesDevelop robust and scalable...
-
Industrial Engineer
1 week ago
Watertown, United States Actalent Full timeJob Description: Industrial Engineer III The Industrial Engineer III is responsible for ongoing process improvement initiatives that deliver excellence across the entire value chain. The Mechanical/Industrial Engineer will utilize enterprise standards to lead process improvement initiatives by implementing policies, procedures, and process documentation...
-
Industrial Engineer
2 weeks ago
Watertown, United States Actalent Full timeJob Description: Industrial Engineer III The Industrial Engineer III is responsible for ongoing process improvement initiatives that deliver excellence across the entire value chain. The Mechanical/Industrial Engineer will utilize enterprise standards to lead process improvement initiatives by implementing policies, procedures, and process documentation...
-
Sustaining Engineer
1 week ago
Watertown, United States Crenlo Engineered Cabs Full timeSUMMARY: The Sustaining Engineer supports Crenlo Engineered Cabs North American facilities (Rochester, Minnesota, Watertown, South Dakota and Greeneville, Tennessee) off-highway cab products currently in production by improving safety in manufacturing of current products, support existing products for ease of manufacture, implement quality improvements and...
-
Engineering Manager
2 weeks ago
Watertown, United States Oxenham Group Full timeThey are currently seeking an Engineering Manager who can lead and inspire a diverse team of automation and manufacturing engineers. In this role, you'll have the opportunity to make a lasting impact by improving manufacturing processes and enhancing product quality—all while working directly with the President and upper management. This is your chance to...
-
Production Engineer
3 weeks ago
Watertown, United States StaffWorks, Inc. Full timeOur client is looking for a Production Engineer! Lots of growth opportunity to move up with a growing company! The Production Engineer is responsible for process ownership and further developing all manufacturing process requirements including batch records, procedures, and training instructions for all current and new product offerings. This position will...
-
Biopharmaceutical Process Development Leader
6 days ago
Watertown, Massachusetts, United States Oruka Therapeutics Full timeOverview of the RoleOruka Therapeutics is seeking an experienced Biopharmaceutical Process Development Leader to join our team. In this role, you will be responsible for leading the development and manufacturing of biologics for clinical and commercial use.About Oruka TherapeuticsWe are a cutting-edge biotechnology company developing novel biologics for the...
-
Electrical Design Engineer
3 weeks ago
Watertown, United States Standex Full timeAn Electrical Design Engineer is a technical professional who is responsible for creating design specifications for a variety of electromechanical components, primarily including but not limited to designs requiring magnetic field mapping and analysis, modeling of electromagnetic systems and incorporating physics of converting mechanical energy to electrical...
-
Electrical Design Engineer
7 days ago
Watertown, United States Standex Full timeAn Electrical Design Engineer is a technical professional who is responsible for creating design specifications for a variety of electromechanical components, primarily including but not limited to designs requiring magnetic field mapping and analysis, modeling of electromagnetic systems and incorporating physics of converting mechanical energy to electrical...
-
Process Development Leader
6 days ago
Watertown, Massachusetts, United States Oruka Therapeutics Full timeAbout Oruka Therapeutics (Nasdaq: ORKA), a pioneering biopharmaceutical company, we're revolutionizing the treatment of chronic skin diseases. Our mission is to offer patients suffering from conditions like plaque psoriasis unparalleled freedom from their condition through high rates of complete disease clearance with infrequent dosing. With a proprietary...
-
Product Safety System Engineer
3 weeks ago
Watertown, United States Boston Dynamics Full timeBoston Dynamics is a world leader in mobile robots, tackling some of the toughest robotics challenges. We combine the principles of dynamic control and balance with sophisticated mechanical designs, cutting-edge electronics, and next-generation software for high-performance robots equipped with perception, navigation, and intelligence. Boston Dynamics has an...
-
Engineer III, Validation
1 week ago
Watertown, United States Thermo Fisher Scientific Full timeWork Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer III, Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: • Draft validation protocols for method crossovers and performance qualification for QC instruments; •...
-
Watertown, Massachusetts, United States Enanta Pharmaceuticals Full timeJob OverviewThe Senior Director, Chemical Process Development and Manufacturing is a critical role at Enanta Pharmaceuticals. We are seeking an exceptional leader with expertise in drug substance development and manufacturing to join our team.Estimated Salary: $250,000 - $350,000 per yearThis position will lead the design, execution, and implementation of...
-
Watertown, United States Oruka Therapeutics Full timeAbout Us:Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing...
-
Manufacturing Design Engineer
6 days ago
Watertown, South Dakota, United States Crenlo Engineered Cabs Full timeAbout the RoleWe are seeking a highly skilled Manufacturing Design Engineer to join our team at Crenlo Engineered Cabs. As a key member of our engineering department, you will play a vital role in optimizing production processes and ensuring the highest quality products.Key Responsibilities:Design for Manufacturability: Develop and implement design solutions...
-
watertown, United States Oxenham Group Full timeThey are currently seeking an Engineering Manager who can lead and inspire a diverse team of automation and manufacturing engineers. In this role, you'll have the opportunity to make a lasting impact by improving manufacturing processes and enhancing product quality—all while working directly with the President and upper management. This is your chance to...
-
watertown, United States Oxenham Group Full timeThey are currently seeking an Engineering Manager who can lead and inspire a diverse team of automation and manufacturing engineers. In this role, you'll have the opportunity to make a lasting impact by improving manufacturing processes and enhancing product quality—all while working directly with the President and upper management. This is your chance to...
