gamp Jobs in michigan

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Sr DeltaV Automation Engineer Onsite

Tektree Systems Inc.

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Muskegon, Michigan, USA

Contract, Third Party

Muskegon, MI - onsite daily We need someone who has developed automation code within DeltaV (Control Modules through to Equipment Modules, Phases and Recipes) and familiar with troubleshooting code errors, not just associates with a background in using DeltaV from on operator perspective. This role entails making changes to software, identifying errors and then testing hence Validation profiles will be DISQUALIFIED. Job Summary: This is an onsite role to help with commissioning efforts of a D
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Posted 60+ days ago | Updated 3 days ago

Senior Staff, Software Quality Assurance Engineer

Stryker

•

Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must resi
Posted 13 days ago | Updated 3 hours ago

DeltaV Automation Engineer

Fynbosys Inc

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Remote or Muskegon, Michigan, USA

Contract

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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Posted 1 day ago

compliance lead

Adva IT Services, Inc..

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Remote

Contract

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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Posted 1 day ago

Sr DeltaV Automation Engineer

Intone Networks Inc.

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Michigan, USA

Full-time, Third Party, Contract

Sr DeltaV Automation Engineer - Muskegon, MI - onsite Job Summary: This is an onsite role to help with commissioning efforts of a DeltaV system and mentor other Junior and Intermediate Engineers. The client and the project team have been working very well together with high collaboration, communication, adaptability, and a good sense of camaraderie making the work environment enjoyable and engaging. We're looking someone who is strong technically but also a great team player, collaborative, an
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Posted 37 days ago | Updated 1 day ago

Lead/Sr Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams
Posted 14 hours ago | Updated 3 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

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
Posted 22 days ago | Updated 3 hours ago

Senior DeltaV Automation Engineer

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Job Description: Are you a DeltaV expert with hands-on experience developing automation code within the DeltaV platform? Do you thrive in a collaborative environment and enjoy mentoring junior engineers? If so, we want to hear from you! Responsibilities: Develop automation code within DeltaV (Control Modules, Equipment Modules, Phases, Recipes). Identify, troubleshoot, and resolve software errors within the DeltaV system. Conduct Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),
Posted 60+ days ago | Updated 3 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

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
Posted 60+ days ago | Updated 3 hours ago

SAP Finance FICO Consultant

URSI Technologies Inc.

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Remote

Contract

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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Posted 17 days ago | Updated 9 days ago

Project Manager - Gxp

Oraapps Inc

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Remote

Contract

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 certific
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Posted 1 day ago | Updated 7 hours ago

Full stack Developer-LAMP

Akshaya Inc

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Remote

Third Party, Contract

Job Title :LAMP Full stack Developer Location: Remote Experience: 15+Years Required Description: Lead efforts to build and migrate features from the current LAMP stack application to Google Cloud using state of the art techstack using NodeJs, VueJS, CloudSQL and Google Cloud technologies. Deep knowledge building full stack apps using VueJS, NodeJS, HTML5, CSS3, JavaScript and microservices. Working knowledge of PHP applications and ideally have experience migrating them.
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Posted 2 days ago

Raw Materials Technical Specialist

Aditi Consulting

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Remote or Cambridge, Massachusetts, USA

Contract

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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Posted 4 days ago | Updated moments ago

Junior Software Developer - Front End

SolvIT

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Rochester Hills, Michigan, USA

Full-time

JOB TITLE: Junior Software Developer Front End REPORTS TO: Software Development Manager JOB TYPE: Full Time DAYS/HOURS: M-F, Standard Business Hours; Occasional Weekends/On-Call Hours LOCATION: 2831 Research Drive, Rochester Hills, MI 48309 This position is hybrid and requires some onsite work. The Junior Software Developer will have the primary responsibility of consulting, architecting, maintaining, and supporting complex Linux System environments for both clients and internal projects. What d
Posted 1 day ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

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.
Posted 60+ days ago | Updated 3 hours ago

SAP S/4 HANA Solutions Architect

TekShapers

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Michigan, USA

Full-time, Part-time, Contract, Third Party

SAP S/4 HANA Solutions Architect Location: Remote Employment Type: Contract (C2C) Job Description: SAP Certified SAP S/4 HANA Solutions Architect with overall 17 years of experience in SAP - S/4 HANA / ABAP on HANA / S/4 HANA Sales / SAP S/4 HANA Sourcing and Procurement/ SAP Solution Manager / SAP APO/GATP and SAP WORKFLOW Module. Currently working as SAP S/4 HANA Solutions Architect and involved multiple end to end Implementation projects in SAP Platform. Experienced on both Support and Impl
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Posted 12 days ago | Updated moments ago

Junior Software Developer - Back End

SolvIT

•

Rochester Hills, Michigan, USA

Full-time

JOB TITLE: Junior Software Developer Back End REPORTS TO: Software Development Manager JOB TYPE: Full Time DAYS/HOURS: M-F, Standard Business Hours; Occasional Weekends/On-Call Hours LOCATION: 2831 Research Drive, Rochester Hills, MI 48309 This position is hybrid and requires some onsite work. The Junior Software Developer will have the primary responsibility of consulting, architecting, maintaining, and supporting complex Linux System environments for both clients and internal projects. What do
Posted 1 day ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 20 days ago | Updated 3 hours ago

Finance Analyst ONLY W2

Aziro Technologies LLC

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Remote

Contract

SKILLS NEEDED Excellent understanding of US GAAP, revenue recognition, and financial analysis, with advanced knowledge in Profit and LossExcellent analytical skillsExcellent business application skills (e.g., Microsoft Excel). Must be able to make pivot tables, analyse revenue, costs, apply procedures, determine actions to be taken and prepare summary reports.Knowledge of SAP ERP, booking manual Journal Entries, Intercompany Billings is mandatorySuperior communication and influencing skills, sho
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Posted 15 days ago

Field Service Engineer I (lab equipment)

Thermo Fisher Scientific

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Colorado, USA

Full-time

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
Posted 14 days ago | Updated 3 hours ago