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Remote or Hybrid in Muskegon, Michigan

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Today

Title : Sr/Lead DeltaV Automation Engineer Location - Muskegon, MI (Onsite) Cognizant JD : This is a remote position open to any qualified applicant in the United States.We are open to considering remote candidates who are willing to travel frequently to client sites at Muskegon MI. Travel Requirement : The travel requirements include an initial three weeks to overlap with another senior engineer. Subsequently, the schedule is anticipated to be two weeks of travel to Muskegon MI followed by thr

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Contract

Depends on Experience

compliance lead

Remote

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Today

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc

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Contract

Depends on Experience

Project Manager - Gxp

Remote

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Today

Job Title -Project Manager Gxp Location - Remote Contract Duration - 6+ Months Requirement: - 8+ years full lifecycle PM experience - Demonstrated PMLC/SDLC experience/success - Ability to quickly adapt to a maturing project environment - Ability to manage multiple concurrent priorities - MS Project and the ability to execute project plan is a must have MUST BE STRONG MS PROJECT - GXP & GMP Experience - Heavy experience required Plus: - GMP project experience, preferably as a PM - PMP certifi

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Contract

Depends on Experience

Raw Materials Technical Specialist

Remote or Hybrid in Cambridge, Massachusetts

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Today

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t

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Contract

$38 - $40 hr

Software Application Programmer/Coder - II

Temple Terrace, Florida

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Today

Location: Temple Terrace, FL Description: Our client is currently seeking a Software Application Programmer/Coder - II Responsible for all aspects of the development & implementation of one large project and provides a single point of contact for those projects - original concept thru final implementation. Functional Expert: Acts independently or member of a highly skilled technical team responsible for fulfilling complex business requirements with the implementation of reliable & efficient a

Contract

SAP Finance FICO Consultant

Remote

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8d ago

SAP Finance FICO Consultant San Francisco, CA Remote Remote Qualifications The ideal candidate will have hands-on experience in SAP S4HANA and ECC, a strong understanding of GAMP 5, cGMP, and SOX compliance requirements, and proven application support skillsKey Responsibilities: Provide application support for SAP FICO modules within a regulated IT environmentTranslate business requirements into SAP solutions using SAP Best Practices, FIORI apps, and embedded analyticsJob description : 9+ to 15

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Depends on Experience

Process Engineer

Remote or New York

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Today

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.

Full-time

Seeq Implementation & Support Consultant-W2 ONLY

Remote

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3d ago

ResponsibilitiesDuring Implementation Phase: Lead release management and environment coordination for Seeq (SaaS) Establish and enforce SDLC best practices, including code workflows and version control Support integration across ~12 data sources (e.g., OSI PI, Data Lakes, Unicorn, Nova) Drive CSV/CSA efforts, including documentation, risk assessment, and audit readiness Contribute to SOP authoring, compliance strategy, and data governance Post-Go-Live Operations: Develop advanced analytics and d

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Contract

Depends on Experience

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

Full-time

Field Service Engineer I (lab equipment)

Remote or Colorado

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Today

Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Field Service Engineer (lab equipment) When you join us at Thermo Fisher Scientific, you'll be part of an inquis

Full-time

USD 23.26 - 38.76 per hour

Sr Technical Operations Training & Support Specialist

Remote or Greenville, North Carolina

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Today

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Sr Technical training and support engineer and have the unique opportunity to build, grow, and share your expertise in the manuf

Full-time

Technical Operations Training & Support Specialist

Remote or Greenville, North Carolina

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Today

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Technical training and support engineer and have th

Full-time

Staff Software Engineer, Manufacturing Engineering

Remote or Atlanta, Georgia

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description About Us: At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. We are revolutionizing the manufacturing industry with brand new technology and innovative solutio

Full-time

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

Mechanical Engineer II

Remote or Lawrence, Massachusetts

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Today

PURPOSE AND SCOPE: The Mechanical Engineer II will play a key role in improving our Home HD products and our patients' lives. This individual will apply sound engineering principles in the support of our current product portfolio and will be involved in different parts of a product's life, including but not limited to the feasibility evaluation for new features and products to improve the quality, performance, and cost of dialysis therapy. You will be part of a team with responsibility for suppo

Full-time

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

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Today

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

Full-time

Director, Engineering - Drug Product Commercialization

Remote or West Point, Pennsylvania

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Today

Job Description Job Description: Director, Center of Excellence for Sterile Drug Product Commercialization Overview We are seeking a dynamic and experienced leader for the role of Director within our Center of Excellence (CoE) for Sterile Drug Product Commercialization. Sterile Drug Product Commercialization is the Company's Manufacturing Division business unit responsible for late-stage development of vaccines, biologics and sterile pharmaceutical drug products. Sterile Drug Product Commerci

Full-time

USD 169,700.00 - 267,200.00 per year

Manager, IT/Senior Systems Analyst

Remote or Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical

Full-time

Sr. Spclst , Technical Support

Remote or Rahway, New Jersey

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Today

Job Description Business Technology Partner Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We partner internationally to deliver the services and solutions that help development scientists to be more productive and enable innovation. The BTP ensures translation of business strategy to IT strategy, relevant communication to business and IT functions, and develop strategic digital roadmaps, and lead delivery of ca

Full-time

USD 104,200.00 - 163,900.00 per year

CSV Engineer

Jacksonville, Florida

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Today

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation departm

Full-time

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