GxP Validation Engineer/Analyst

Responsibilities: Collaborate with stakeholders to gather and define requirements for validation activities Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Perform risk assessments to identify critical and non-critical systems and validate...

We are looking for a Business System Analyst to gather requirements, UAT, and create presentations. Strong understanding and working knowledge of: GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2) Clinical Trial Data (STDM, ADaM, DTD, eCTD/XML) Implementing data platforms and services. Experience selecting, designing and...

Interview : Video Visa : All apart from h1b and cpt This is hybrid from day-1 Description: My pharmaceutical client is looking for 2 Business Analysts to come into Cambridge, MA 2-3 times per week **10 plus years of GXP BA experience Technical Business Analyst **Work with data management and set up processes toward policies on how they manage and...

The IT Support Analyst provides on-site IT support for a fast-paced Cell Therapies manufacturing facility at a global Biopharmaceutical company based in Cambridge, MA. The position is responsible for supporting IT scientific laboratory operations and requires IT administration expertise, along with basic knowledge of the GMP validation.ResponsibilitiesServes...

Job Description About This Role The R&D IT Senior Business Analyst (BA) will play an active role in supporting GXP applications in the Clinical Sciences business area, specifically the electronic Trial Master File (eTMF). The BA has responsibility for the health and success of eTMF and related projects within a matrixed organization with direct...

DUTIES:Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives;Act as a subject matter e Validation, Mechanical Engineer, Chemical Engineer, Electrical Engineer, Biochemical Engineer

Pay 80-85/hour W2. Our company offers our consultants a suite of benefits after a qualification period including health, vision, dental, life and disability insurance. W2 candidates only, C2C not possible for this role. Manager Updates Can be remote but the manager prefers a candidate local to Cambridge, MA as he would like for them to come into the office a...

Pay 80-85/hour W2. Our company offers our consultants a suite of benefits after a qualification period including health, vision, dental, life and disability insurance. W2 candidates only, C2C not possible for this role. Manager Updates Can be remote but the manager prefers a candidate local to Cambridge, MA as he would like for them to come into the office...

QA Specialist - Contract - OnsiteProclinical is seeking a QA Specialist - Equipment and Computer Systems to join a global biopharmaceutical company. This is a contract role located in Cambridge, MA.Skills & Requirements:Specialization in Vaccines - Life science - Bioinformatics - Computer Engineering - Regulatory Requirements in Pharmaceutical...

About the Job The Lead Automation Engineer works as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation...

About the JobThe Lead Automation Engineer works as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation...

Job Title SeniorSupport AnalystIDBS ELN Relevant Experience(inYrs) 8-10years Must Have Technical/Functional Skills Experience of working inGxP environment and practices Good Knowledge ofconfiguration, workflow, development, and maintenance of IDBS BioBook,Workbook of over 4 years Hands on experience inresolving integration, hierarchy administration,...

We are seeking a Research Engineer, in the Traverso Lab at Brigham and Women's Hospital with a background in analytical chemistry. Our research group consists of an interdisciplinary team of engineers, chemists, biologists, pharmaceutical scientists, and physicians focused on developing clinically translatable biomedical devices and drug delivery...

Roles & Responsibilities Monitor manage and ensure delivery of projects in a deadline-driven environment. Author Technical SDLC deliverables Technical assistance for testing preparation and implementation of enhancements Contribute to the creation of operational support documentation Drive technical delivery and accountability of internal staff as well as...

Roles & Responsibilities Monitor manage and ensure delivery of projects in a deadline-driven environment. Author Technical SDLC deliverables Technical assistance for testing preparation and implementation of enhancements Contribute to the creation of operational support documentation Drive technical delivery and accountability of internal staff as well...

Job Title: Information Systems Engineer Location requirements/Schedule: Onsite Location/s: : 45 Sidney St. Cambridge MA. 02139 Start Date: ASAP Bonus/Benefits: NO Type of contract: C2C, W2, Contract to Hire – W2 Duration: 4 Months Visa: USC, GC How many interviews: 2 Interview Process: Video Important Skills: AWS, Vmware, Microsoft Shop/Linux Must Haves :...

Job Description Job Description The Senior Analyst will be responsible for driving forward the performance, and operations of EverQuote's top-priority projects. This person will leverage extensive data insights, they will identify opportunities, enhance real-time reporting, optimize user experiences, and address operational gaps. This person will be...

The Senior Analyst will be responsible for driving forward the performance, and operations of EverQuote's top-priority projects. This person will leverage extensive data insights, they will identify opportunities, enhance real-time reporting, optimize user experiences, and address operational gaps. This person will be responsible for identifying issues and...

Job DescriptionJob DescriptionThe Senior Analyst will be responsible for driving forward the performance, and operations of EverQuote's top-priority projects. This person will leverage extensive data insights, they will identify opportunities, enhance real-time reporting, optimize user experiences, and address operational gaps. This person will be...

Location: Cambridge, MA Vaxess Technologies is developing next generation vaccines and therapies based on its proprietary MIMIX™ Microneedle Array Patch technology. MIMIX™ enables self-administration of vaccines and therapeutics to the skin with potential for improved shelf-stability, tolerability, and efficacy. We are committed to enabling products...