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Retention, Development, and Integration Manager

🔖 Full Time

📑 Development, Retention, & Integration ManagerKatalyst Group, in partnership with a local professional services organization, is currently seeking an HR professional with leadership and development experience. Ideal candidates will have a minimum of 5 years' experience developing and implementing employee engagement strate ...

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Regional VP of Sales, Life Sciences

🏢 RLDatix
📌 United States, United States, United States
💼 other general
⌚ 16 hours ago

🔖 Full Time

📑 RLDatix Life Sciences, a subsidiary of RLDatix, is a leading provider of comprehensive solutions in the life sciences industry. Formed through the integration of Porzio Life Sciences, iContracts, and iCoachFirst, RLDatix Life Sciences offers cutting-edge compliance solutions, advanced revenue management, and strategic coaching and trai ...

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Head of Business Development

🔖 Full Time

📑 Katalyst is at a pivotal moment of growth. We have been building momentum. The next 18 months will bring massive change and rapid scaling. We have greased the wheels, and now we are ready for someone to take us to the next level as our first fully dedicated Business Development professional. If you’re excited about getting in at the ground level an ...

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Account Executive

🏢 MJH Life Sciences
📌 United States, United States, United States
💼 other general
⌚ 16 hours ago

🔖 Full Time

📑 At MJH Life Sciences our success is measured by your success! If you set your standards high and want to contribute to a winning team, we’ll provide you with every opportunity to help grow our company and your career. Our associates come from all backgrounds, sharing one key quality: determination to succeed. We value being Service Focused ...

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Manager - Life Sciences

🔖 Full Time

📑 **Join a Leading Management Consulting Firm in Life Sciences!**Our client is seeking experienced Life Science Case Managers for their USA Offices on both the East and West Coasts (San Francisco and Boston). This is your opportunity to embark on a fast-track career path, working with Global Pharma Leaders and an international team of exceptional pro ...

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Superintendent - Life Sciences

🏢 Daksta | Connecting Mission Critical Talent
📌 United States, NC, United States
💼 other general
⌚ 5 days ago

🔖 Full Time

📑 What's the opportunity?How does joining an rapidly growing life science division with an established Global EPC firm sound?We're working with a global corporation who are growing their new Life Sciences line of business on the East Coast. Their people are their success and each have the opportunity to contribute to a innovative culture and influenc ...

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Tech 2, Operations Facilities Maintenance

🔖 Full Time

📑 Responsibilities: Operations Maintenance is responsible for managing the service life of company assets which is inclusive of physical building and utilities, manufacturing/ warehouse equipment and tooling, office devices and physical layout of facility. This responsibility is completed through the management of appropr ...

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Design Assurance Engineer

🔖 Full Time

📑 Responsibilities: Lead all quality elements of Design Controls and product DHF for design projects. Drive Quality norms associated with design engineering projects. Support integration of Risk Management processes throughout the product lifecycle from initial. development through post market su ...

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Process V & V NPD Engineering

🔖 Full Time

📑 Responsibilities: Works independently with limited direction. Performs material tests. Performs activities of process/product validation. Performs DOEs and process characterization. Proficiency in protocol and test report documentation Proficiency in Statistics, Gage R & R Studies ...

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Tech 2, Equipment Maintenance

🔖 Full Time

📑 Responsibilities: Performs routine set up, operation, minor and major routine maintenance, preventative maintenance (PM) and troubleshooting of highly complex/automated manufacturing equipment.Controls and adjusts machine settings.Responsibilities include production, quality, downtime and waste levels of machine operation. P ...

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Clinical SAS Programmer

🔖 Full Time

📑 Responsibilities: Attending multi-disciplinary team meetings, representing the programming function. Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) Create or ...

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Operator 1, Warehouse Operations

🔖 Full Time

📑 Responsibilities: The essential duties of the Warehouse Spore Placer are the following: Exercise Safe lifting techniques when bending, lifting, and turning. Accept materials from other Client divisions / departments for ethylene oxide sterilization. Verify the catalog numbers, lot numbers, quantities and exp ...

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Validation Engineer

🔖 Full Time

📑 Responsibilities: Develop, review, and approve validation testing and protocols for cleanrooms and environments in conjunction with other validation team members. Provide support to Engineering, Maintenance, Manufacturing, and QA teams during Protocol execution. Develop, review, and approve validation testing and pro ...

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Quality Engineer

🔖 Full Time

📑 Responsibilities: This individual will come from a Medical Device background with strong experience in quality engineering. This consultant will be expected to be capable of writing procedures for the client independantly. This person should have experience with FMEAs, and be comfortable with tasking on documents f ...

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Scientist 2, Biology

🔖 Full Time

📑 Responsibilities: Responsible for the execution of experiments with varying complexity using multi-color Flow Cytometry.Independently analyze own research data, solve problems with minimal guidance and effectively plan follow up experiments.Demonstrated ability to interpret and present data of moderate to high complexity wit ...

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CSV Engineer

🔖 Full Time

📑 Responsibilities: Project management, including timeline and resources, coordination with QA management regarding priorities and organization of departmental resources to support CSV activities (i.e., validation resources, as well as IT and business process owners). Work with Manufacturing (MFG), Facilities (FAC), Quality Control (Q ...

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CSV Engineer

🔖 Full Time

📑 Responsibilities: Author Qualification (IQ/OQ) Final Reports for Application upgrade projects. Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, co ...

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Operator 1, Warehouse Operations

🔖 Full Time

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Staff Packaging Engineer

🔖 Full Time

📑 Responsibilities: Subject matter expertise (SME) on packaging design for Class II and III medical device, pharmaceutical and combination products. Technical leader of the design, development, and qualification of packaging systems for new and existing products. Independently develops and drives strategies for: Desig ...

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Clinical SAS programmer

🔖 Full Time

📑 Responsibilities: Serves as the primary project team representative, delegating work as appropriate Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains Generates analysis data sets, tables, figures, and listings to support the analysis of ...

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Validation Expert

🔖 Full Time

📑 Responsibilities: Understand and able to review vendor Qualification document package in line with regulatory requirements. Knowledge of System and Functional Risk assessment / management, defining risk mitigation plan Should have good Stakeholder management skills to interact with customer, business, and vendors ef ...

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Tech 2, Equipment Maintenance

🔖 Full Time

📑 Responsibilities: Performs routine set up, operation, minor and major routine maintenance, preventative maintenance (PM) and troubleshooting of highly complex/automated manufacturing equipment. Controls and adjusts machine settings. Responsibilities include production, quality, downtime and waste levels of machine o ...

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Industrial Engineer

🔖 Full Time

📑 Responsibilities: Experience in performing Video based time studies and work breakdown activities.Perform Line Balancing Studies using Yamazumi charts.Identify process improvement and support in productivity improvement initiative.Should have experience in high volume and high mix production environment.Exper ...

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Quality Assurance Specialist

🔖 Full Time

📑 Responsibilities: Quality Assurance Specialists working in one of our distribution centers are responsible for enforcing our cGMP practices on-site. Report any concerns or opportunities for improvement to the QA Safety & Facilities Manager. Provide cGMP and controlled document training for new hires and refresher tr ...

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Operator 1, Warehouse Operations

🔖 Full Time

📑 Responsibilities:Complete ERP System Transactions using computer or handheld scanner.Maintain communication with team and internal customers via Microsoft Outlook and Teams.Read customer orders accurately to identify part number, quantity ordered, and location.Locate and select specific inventory items to fulfill ord ...

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Validation Engineer

🔖 Full Time

📑 Responsibilities: Strong knowledge/experience with LIMS (Laboratory Information Management System), Softmax , ELN (Electronic Lab Notebook) products. Good understanding of Pharma CSV (Computer Systems Validation). Knowledge of CSA (Computer system Assurance). Work with business users to understand the busin ...

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Sr Quality Assurance Specialists

🔖 Full Time

📑 Responsibilities: Deviations & CAPA Mastery: Leverage your 10+ years of experience handling deviations and corrective action/preventive action (CAPA) processes to lead investigations, identify root causes, implement effective remediations, and ensure long-term corrective action prevents recurrence. Championing Data Integrity ...

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Multimedia Engineer

🔖 Full Time

📑 Responsibilities: Total 7+ Years of Exp ! Min 4+ Hands on experience with various Platform SW components for multiple embedded platform - Linux systems. Strong C/C++ and system level Linux working experience Full stack development experience, , Triaging & Bug fixing issues , System Integration experience. S ...

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Validation Engineer

🔖 Full Time

📑 Responsibilities: 2-5 years of experience in manufacturing and/or process engineering. Development of specifications and user requirements for new equipment that supports manufacturing operations Planning, development, and execution of equipment/process qualifications as it relates to CNC machining, manufacturing, i ...

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Senior Quality Engineer

🔖 Full Time

📑 Responsibilities: Will be responsible for managing quality related problem solving and continuous improvements opportunities.Lead / Support Change Control to manage business needs and continuous improvement activities.Provide guidance and approvals of applicable validations and change control documentation.Manage NC/ ...

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Sr. Supplier Quality Engineer

🔖 Full Time

📑 Responsibilities: Maintaining relationships with key suppliersDeveloping supplier performance metrics, tracking KPIs, and driving improvementsResolving supplier non-conformances in the production process by identifying the root cause and implementing solutionsAssist with external audits.Travel on-site to supp ...

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Machinist

🔖 Full Time

📑 Responsibilities: Not a machine operatorResponsible for stepping in to repair machine breakdowns.Troubleshoot problems.Speed of operation issuesWaste issues.Must have mechanical hands-on background.Made up of components that translate across other industries. Bonus, has high speed manu ...

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Quality Manager

🔖 Full Time

📑 Responsibilities: Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed Ability to work independently on problems and issues and determine acceptable solutions and approaches Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS result ...

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Regulatory Affairs Specialist II

🔖 Full Time

📑 Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product develo ...

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QA Validation Specialist

🔖 Full Time

📑 Responsibilities: Managing Quality Engineering and Validation (QEV) Validation programs for the facilities, utilities, manufacturing and QC lab equipment, computerized systems and associated processes. Responsible for maintaining and ensuring site compliance to corporate policies and procedures for the validation of system ...

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Validation Engineer

🔖 Full Time

📑 Responsibilities: Generation of protocols, summary reports, and protocol exceptions Scheduling and execution of qualification activities Qualification data collection and analysis against acceptance criteria Documentation updates (SOPs, Forms, etc.) Meeting attendance and project coordination 7+ yea ...

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Qualification Engineer

🔖 Full Time

📑 Responsibilities: Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs), and all other regulatory requirements including GAMP5. Executes test plans acc ...

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Validation Lead

🏢 Katalyst Healthcares & Life Sciences
📌 Pennsylvania Furnace, PA, United States
💼 other general
⌚ 16 hours ago

🔖 Full Time

📑 Responsibilities: 10 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end v ...

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Validation Consultant

🔖 Full Time

📑 Responsibilities: Validation Planning and Strategy: Develop and implement validation plans and strategies in alignment with current Good Manufacturing Practices (cGMP), FDA, EMA, and other regulatory guidelines. Commissioning, Qualification, and Validation (CQV): Lead and execute CQV activities for manufacturing equipment, f ...

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Clinical Data Manager

🏢 Katalyst Healthcares & Life Sciences
📌 South San Francisco, CA, United States
💼 other general
⌚ 16 hours ago

🔖 Full Time

📑 Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies.Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing.Monitor data collection, coding, and ...

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QA Specialist

🔖 Full Time

📑 Responsibilities: Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Serves as Analytical Operation Lead for clinical and commercial projects. Leads quality investigations/deviations/quality event escalation meetings, and effectively communicate ...

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Senior Validation Consultant

🔖 Full Time

📑 Responsibilities: Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements. Prepare training materials and perform training and coaching for all team members. Perform validation of products and services and qualification of software/ ...

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Quality Engineer

🔖 Full Time

📑 Responsibilities: A minimum of Technical/Engineering Degree with 8+ years of related experience Medical Device Supplier Quality domain.? Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other internation ...

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CSV Validation Engineer

🔖 Full Time

📑 Responsibilities: You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documenta ...

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Senior Quality Validation Engineer

🔖 Full Time

📑 Responsibilities: Plans, implements a robust cleaning and sanitization program by authoring and leading the sanitization Validation Program for all products and product contact equipment. Leads the execution of the cleaning and sanitization validations by authoring protocols, hands on execution of the protocols and authoring ...

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Quality Engineer

🔖 Full Time

📑 Summary: Responsible for ensuring that materials, goods, and services meet Customer and Quality requirements. Maintains the Quality System to comply with regulatory requirements. Leads continuous quality improvement activities. This is a hands-on position that works with Customers and all functions and levels wit ...

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Regulatory Affairs Specialist

🔖 Full Time

📑 Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in reviewing of quality documents such as Reformulation studies, process val ...

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Quality Engineer

🔖 Full Time

📑 Responsibilities: Perform failure analysis on explanted long-term biomedical implant product. Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical. Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross- Proactive i ...

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Validation Engineer

🔖 Full Time

📑 Responsibilities: Determine project scope and strategy with client groups and other stakeholders to execute small and large capital projects in a cGMP environment. Participate in the development of the following Validation efforts: Validation Planning, Protocol Generation, Protocol Execution, Familiar with GAMP/GMP process, ...

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Scientist 2, Biology

🔖 Full Time

📑 Responsibilities: Routine, accurate and timely completion of all assigned experimental tests. Will be expected to efficiently prioritize individual workload. Independently analyze research data, solve problems with appropriate guidance and effectively plan follow up experiments. Responsible for the execution of experiment ...

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