Senior Computerized Laboratory Equipment Consultant for GxP Implementation and Validation

5 days ago


Copenhagen, Copenhagen, Denmark Pharma IT Full time
Senior Computerized Laboratory Equipment Consultant for GxP Implementation and Validation

To support our growing customer portfolio in our QC laboratory domain, Pharma IT is searching for an experienced Computerized Laboratory Equipment Consultant for GxP Implementation and Validation to join our Laboratory IT consulting team.

Pharma IT's Laboratory IT team boasts over 100 years of combined experience. Our team's key focus is laboratory equipment implementation and validation but we also work with implementation, integration and upgrade projects of corporate laboratory systems.

You will get the opportunity to impact some of our customers' most exciting laboratory IT projects and support the evolution of the laboratory landscape within the Life Sciences industry.

In this role, you will work in close collaboration with our specialized Lab IT team and other Pharma IT staff, the client's own team, or both. You will support our clients with diverse lab instrument/equipment related assignments according to your expertise areas.

KEY RESPONSIBILITIES for this position include:

  • Work independently, or together with other team members, in a GxP compliance framework to implement complex scientific laboratory equipment in pharmaceutical QC laboratories.
  • Engage both with our clients QC staff and with instrument/equipment vendors to drive an effective implementation and validation process of multiple pieces of computerized equipment.
  • Create compliance documentation and act as a GAMP 5 compliance advisor for our clients.
  • Be our clients' subject matter expert within IT/equipment compliance and validation in the QC laboratory.

The IDEAL CANDIDATE for this role ...

  • (MANDATORY) Has a minimum of 6 years of experience with Laboratory IT in the pharmaceutical domain. Having a background as a lab technician, microbiologist, chemist or similar is an additional advantage.
  • (MANDATORY) Since our clients expect our consultants to work on site 2-3 days per week, the candidate must be currently based in Denmark.
  • Has experience in setting up and configuration of laboratory instrument computers according to specifications and configuration of laboratory instrument software.
  • Has strong stakeholder management skills and an ability to communicate and motivate across stakeholder groups spanning from Line of Business, IT back end, and QA -- especially bridging between QC lab technicians and IT.
  • Is able to work independently with our clients with limited managerial interaction, but enjoys sparring with peers.
  • Has a strong consultancy mindset, including having a positive attitude towards our clients and capability to grow your assignments with the clients you work for.
  • Works in a structured manner with an eye for detail, while remaining pragmatic and keeping an overview of your deliverables and progress.
  • Is motivated by the idea of working within an organization with highly experienced Laboratory IT consultants.
  • Is results-oriented and committed to contributing to the overall success of our clients and Pharma IT.

Applicants should highlight the following technical expertise in their applications:

  • Technical knowledge around network, integration and firewall.
  • Understanding of GxP.
  • Computer setup with security settings, user management, backup and active directory.
  • Experience with technical writing e.g. instrument maintenance SOP's and from writing and execution of IQ/OQ.

PHARMA IT:

Pharma IT aims to deliver price-competitive young talent and experienced professional consultants to the pharma, biotech, and medical device industries. Our exclusive focus on these industries and agile, customer-oriented approach ensures we maximize customer value. We assist clients across all key areas of these industries, including: Management & Business Consulting, IT Consulting, Drug Development, Medical Device Consulting, Manufacturing Consulting, Quality, Compliance & Security Consulting.

Our team consists of more than 130 diverse and talented consultants, and we are currently experiencing rapid growth. We encourage people of all ages, genders, sexual orientations, nationalities, religions, and ethnic backgrounds, to apply.

BENEFITS:

Pharma IT offers industry-leading contracts and work-life balance. We offer a base salary with an accelerated bonus model as part of what we believe is one of the best employment packages in the industry. Our core belief is that employees should have flexible hours, do what they are best at, and be able to spend as much time at our customers' sites as possible.

HOW TO APPLY:

This position will be filled on a rolling basis. Interested applicants should apply as soon as possible via LinkedIn.

For more information please contact the hiring manager for this position, Stig Ragborg

(Director of Laboratory IT) at + 45 21842423

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Consulting, Information Technology, and Other

Industries

Pharmaceutical Manufacturing and IT Services and IT Consulting

#J-18808-Ljbffr

  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    We are searching for a skilled GxP Compliance Expert to join our team. As a key member of our Laboratory IT consulting team, you will work closely with our clients to implement complex scientific laboratory equipment in pharmaceutical QC laboratories.Your primary responsibility will be to work independently or in collaboration with other team members to...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    At Pharma IT, we are seeking an experienced Senior Computerized Laboratory Equipment Consultant to join our growing team. As a key member of our Laboratory IT consulting team, you will work closely with our clients to implement complex scientific laboratory equipment in pharmaceutical QC laboratories.Your primary responsibility will be to work independently...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Senior Laboratory IT Specialist Job DescriptionWe are seeking an experienced Senior Laboratory IT Specialist to join our team. As a key member of our Laboratory IT consulting team, you will work closely with our clients to implement complex scientific laboratory equipment in pharmaceutical QC laboratories.Your primary responsibility will be to work...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Laboratory IT Consultant Job DescriptionAs a Laboratory IT Consultant at Pharma IT, your role will involve implementing and validating computerized laboratory equipment in pharmaceutical QC laboratories. This requires close collaboration with our clients' QC staff and instrument/equipment vendors to drive effective execution.You will need to work...


  • Copenhagen, Copenhagen, Denmark Greatercph Full time

    About the Role">You will be part of the Facility & Equipment validation department, where currently 14 highly qualified team members are waiting for you. We share a fun/relaxed tone while at the same time have high ambitions to deliver best in class validation/qualification activities across the entire organization, to benefit our global biopharmaceutical...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    Hamlyn Williams is a leading consulting firm in the pharmaceutical industry. As a Validation Engineer with our client, you will be responsible for ensuring the quality and safety of their products.The ideal candidate will have experience with SDLC methodologies and strong knowledge of steam sterilizers, autoclaves, lyophilizers, depyrogenation tunnels, smoke...


  • Copenhagen, Copenhagen, Denmark Greatercph Full time

    Senior IT Validation Scientist page is loadedSenior IT Validation ScientistApply locations Copenhagen, Denmark time type Full time posted on Posted 30+ Days Ago job requisition id JR101494Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work...


  • Copenhagen, Copenhagen, Denmark Greatercph Full time

    Senior IT Validation Scientist page is loaded Senior IT Validation Scientist Apply locations Copenhagen, Denmark time type Full time posted on Posted 30+ Days Ago job requisition id JR101494 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is an international biotechnology company committed to developing innovative antibody therapeutics that transform patient care. We are dedicated to creating next-generation antibody technology platforms and leveraging translational research and data sciences to push the boundaries of what is possible.About Our MissionWe strive to make a meaningful...

  • IT Validation Lead

    1 week ago


    Copenhagen, Copenhagen, Denmark Greatercph Full time

    About the Role">We are seeking a highly skilled IT Validation Lead to join our team in Facility & Equipment Validation at AGC Biologics. The successful candidate will be responsible for performing computerized qualification tests and protocols, compiling data and completing validation reports for implementation of new software. ">


  • Copenhagen, Copenhagen, Denmark Ubique Systems Full time

    IT Compliance Lead with exp in GxP and Pharma preferredThe IT Compliance Lead is responsible for defining and executing Validation and qualification strategy for the development and implementation of Genetics Analysis Platform, a Non-GxP SaaS solution, and subsequently another upcoming solution.The IT Validation and Compliance Partner is responsible for...


  • Copenhagen, Copenhagen, Denmark Ubique Systems Full time

    The Ubique Systems' IT Compliance Lead will define and execute a validation strategy for the development and implementation of a Non-GxP SaaS solution, Genetics Analysis Platform. The role is responsible for ensuring that systems are in compliance with internal and external regulatory requirements.Key responsibilities include delivering end-to-end...


  • Copenhagen, Copenhagen, Denmark Fusion Cons Full time

    Job RequirementsWe are seeking a highly skilled Senior Infrastructure Architect to support industrial automation and IT systems in GxP-regulated environments.The successful candidate will have a strong understanding of compliance, architecture frameworks, and manufacturing IT layers, particularly in relation to the Purdue Model.This role requires immediate...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    Hiring Manager: Hamlyn Williams We are a leading consulting firm in the pharmaceutical industry, specializing in recruitment and staffing solutions for the life sciences sector. We help our clients find the best talent for their teams, and we're now looking for a talented Validation Engineer to join our network.The ideal candidate will have experience with...


  • Copenhagen, Copenhagen, Denmark Greatercph Full time

    Job DescriptionThis role offers the opportunity to drive validation activities end-to-end for computerized software.Key Responsibilities:Performing qualification tests and protocols, compiling data and completing validation reports for new software implementation.Oversight of validation activities from planning, execution to completion.Updating procedures...

  • Validation Lead

    1 week ago


    Copenhagen, Copenhagen, Denmark Greatercph Full time

    Job SummaryThis is a unique opportunity to shape the validation direction for computerized software in AGC Biologics.Main Responsibilities:Driving validation activities end-to-end for computerized software.Collaborating with the team to ensure compliance with GMP/IT/validation requirements.Developing and implementing efficient validation...


  • Copenhagen, Copenhagen, Denmark Fusion Consulting Full time

    Senior Infrastructure Architect - GxP-Regulated Environments1 day ago Be among the first 25 applicantsCompany DescriptionFusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health. With over 450 employees and 25 offices...


  • Copenhagen, Copenhagen, Denmark Ubique Systems Full time

    As a key member of the Ubique Systems' team, the IT Compliance Lead will be responsible for defining and executing a validation strategy for the Genetics Analysis Platform. This Non-GxP SaaS solution requires close attention to ensure compliance with internal and external regulatory requirements.The role involves delivering end-to-end documentation,...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About UsGenmab A/S is an international biotechnology company driven by a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics.We're committed to fostering a workplace culture that values diversity, equity, and inclusion at all levels of the company. Our exceptional team of dedicated individuals strives for...


  • Copenhagen, Copenhagen, Denmark Greatercph Full time

    In this role, you will be responsible for shaping the validation/qualification direction for computerized software at AGC Biologics. As Senior IT Validation Scientist, you will oversee the entire validation process, ensuring that all activities meet the highest standards of quality and compliance.">Your Key ResponsibilitiesDevelop and execute comprehensive...