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 four 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 are 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
- Deep insight into GAMP 5, Eudralex vol 4 Annex 15
- 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