For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Laboratory Systems Consultant is responsible for supporting the implementation, validation, and ongoing delivery of laboratory informatics systems such as Electronic Laboratory Notebooks (ELN) and Laboratory Information Management Systems (LIMS) within a regulated pharmaceutical or biopharmaceutical environment. This role focuses on writing and executing User Acceptance Testing (UAT) and validation test scripts, performing unit testing for each sprint release, and translating laboratory and business needs into clear, traceable system requirements. The consultant will work closely with laboratory stakeholders, IT, quality teams, and vendors to ensure system quality, compliance, and successful adoption.
Essential Functions:
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Support the implementation, configuration, and enhancement of laboratory systems, including Electronic Laboratory Notebooks (ELN) and Laboratory Information Management Systems (LIMS).
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Author User Acceptance Testing (UAT) protocols, validation test scripts, and related documentation in compliance with GxP requirements.
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Execute UAT, validation, and regression test scripts and document results, deviations, and remediation efforts.
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Perform unit testing for each sprint release within an Agile development environment.
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Gather, analyze, and document business and laboratory requirements.
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Maintain traceability between system requirements, test cases, and validation deliverables.
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Collaborate with laboratory users, IT teams, quality, and system vendors to ensure successful system delivery and adoption.
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Support issue resolution, defect tracking, and system readiness for production release.
Necessary Skills and Abilities:
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Strong knowledge of computerized system validation (CSV) in regulated pharmaceutical environments.
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Working knowledge of laboratory systems, including:
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Electronic Laboratory Notebooks (ELN)
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Laboratory Information Management Systems (LIMS)
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Laboratory Execution Systems (LES) / Manufacturing Execution Systems (MES)
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Electronic Quality Management Systems (eQMS)
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Ability to write clear, detailed requirements, test scripts, and validation documentation.
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Experience working within Agile or Scrum-based delivery models.
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Strong analytical, problem-solving, and organizational skills.
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Effective communication skills with the ability to work across scientific, technical, and quality teams.
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High attention to detail and commitment to data integrity and compliance.
Educational Requirements:
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Minimum B.S./B.A. in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Engineering, Computer Science or related field)
Experience Requirements:
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Minimum 5 years of experience in the Pharmaceutical or Biopharmaceutical industry.
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Proven experience supporting laboratory informatics systems and validation activities.
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Hands-on experience working in a laboratory setting is preferred.
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Prior experience writing and executing UAT and validation test scripts in a regulated environment.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
