- Merck & Co. (Durham, NC)
- …relate to laboratory testing start-up, regulatory requirements for new assay development/ validation , project timelines and budgeting.Build knowledge of the ... Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing for the BCG Product. The position will focus on… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... organization, the Digital Project Manager will streamline the execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives… more
- Merck & Co. (Rahway, NJ)
- …medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to positively… more
- PSC Biotech (Jacksonville, FL)
- …(GMP, GAMP, etc.). Additional responsibilities as required to drive successful validation project deliverables. Requirements Bachelor's degree in Engineering, ... and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and… more
- Barry-Wehmiller Companies (Boston, MA)
- …with all levels of management, clients, and vendors Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities ... to build a better world. Job Description: Job Description: Validation Engineer Who You'll Work With You will join...is desired Minimum of 3 years project experience in the pharmaceutical, biotechnology, or medical device… more
- Merck & Co. (Rahway, NJ)
- …GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and ... approve qualification protocols and summary reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This ... position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best… more
- LanceSoft (Carlsbad, CA)
- … programs are compliant with Corporate Client and global regulatory expectations. Validation : *Support project validation planning by writing and ... *Meet established validation milestones according to approved validation plans in accordance with overall project ...approved validation plans in accordance with overall project timeline * Validation execution according to plan,… more
- BioAgilytix (Durham, NC)
- …team is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical ... studies-including project scope definition, proposal preparation, timelines, scheduling, budget, and...someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and… more
- Twist BioScience (South San Francisco, CA)
- …requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing ... capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES solutions comply with GxP regulations… more
- Merck & Co. (Rahway, NJ)
- …thinking to advance ADC, Complex Biologics and Small molecule portfolio. Project management skillsAttention to technical detailBuilds collaborations across internal ... writing / review of regulatory filings including INDs and NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT,… more
- Repligen (Rancho Dominguez, CA)
- …a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at our Rancho ... manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes projects or… more
- Project Farma (Washington, DC)
- …footprint in the world. We are an industry leader in providing project management, validation , engineering, quality/compliance, and consulting services to ... best and the brightest to join our high performing organization as a Consultant, Project Controls Engineering. As a leader within the life science industry, we are… more
- Merck & Co. (North Wales, PA)
- …and safety evaluation.The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- BioAgilytix (San Diego, CA)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... client engagement, project delivery, and cross-functional collaboration.Essential ResponsibilitiesLead team(s) developing and validating bioanalytical assays for… more
- Aequor (Tampa, FL)
- Carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of ... QC chemist to provide the method technology transfer and project preparation work, make sure the project ...and regulatory audits as area SME. Develops and executes validation protocols for test methods and equipment qualification. Author… more
- Eisai, Inc (Exton, PA)
- …(as required). The Associate Director sets strategic directions and project priorities, providing scientific leadership and oversight and managing individual ... suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting… more
- Sotera Health Services, LLC (Charlotte, NC)
- …also provide management with information and data on all key aspects of each customer's validation project within the region, which is used by both the plant and ... products sterilization required. Must have experience in writing and executing validation protocols. Customer service and project management experience desired.… more
- Aequor (Thousand Oaks, CA)
- …at ATO B20. The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a ... Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading… more
- Merck & Co. (Rahway, NJ)
- …communication to cross-functional stakeholders, including external suppliers.-Proactively resolve project obstacles and challenges and communicate device development ... and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management, and organizational skillsWilling to travelAble to quickly… more
