Job Location: Philadelphia, PA
Job Detail:
Philly Area (Onsite/Hybrid)
Job Overview
Joining a global biotech research organization as a member of the IT GxP Compliance team, you will be responsible for supporting the overall lifecycle management of the applications used to support a range of regulated processes and activities across the cell and gene therapy manufacturing and testing businesses. You will work with stakeholders to ensure business needs are accurately captured and corresponding system solutions are fit-for-purpose and achieve desired results
The main responsibilities will be the documentation, testing, and validation of various GxP lab applications through implementations and upgrades.
This is a hybrid onsite role: ideally 2-3 days/week onsite, open to some flexibility
What Youll be Doing
- Participate in the development of a structured plan for application lifecycle management for laboratory systems.
- Perform enterprise analysis by planning and scoping several inter-related initiatives and helping senior-level business stakeholders make informed decisions about which initiatives to execute and how to execute
- Participate in GxP qualification/validation activities as needed including writing, reviewing, and executing validation protocols.
- Join working sessions with business end users, IT representatives, and vendors to determine and document both current-state and future state processes, workflow diagrams, and requirements.
- Work with the IT technical delivery team(s) for translation of business requirements into solution, whether commercial applications or new development.
- Facilitate business requirements gathering to elicit, analyze, and document clear and concise user requirements/stories.
- Work cross-functionally with System Owners, IT, and QA Representative for Equipment/Software Validations and provide expertise on equipment/software validations.
- Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements.
- Assist with creation of test plans and detailed test cases to validate that functional requirements are met. When appropriate, lead UAT efforts to ensure the software implementation meets the needs of business end users.
- Maintain a log of any issues identified during testing.
- Assist with the writing, execution, review, or approval of Equipment and Software Validations (IQ, OQ, PQ); work with IT and applicable system vendors in creating test scripts as required.
- Collaborate with testing and manufacturing personnel, system vendors, IT, and QA to support new systems introduction for GxP use.
- Contribute to the authoring of various documents, such as:
- business case/project charter, URS/FRS, impact/risk assessments, vendor/supplier assessments, design/configuration specifications, requirements traceability matrices, test plans, qualification protocols and summary reports, training documentation, and end user SOPs.
- Stay current with changes to GxP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).
What Youll Bring
- 4+ years experience as a business analyst
- Proven experience supporting GxP environments in the life sciences, biotech, pharmaceutical or similar scientific industry.
- Demonstrated experience with SDLC processes, iterative development methodologies, and CSV.
- Strong documentation knowledge.
- Strong experience in testing/validation of software applications.
Bonus if You Have:
- Experience with GxP laboratory systems:
- CMMS, Blue Mountain RAM, ELPRO, Rees Scientific, Empower CDS, SCADA, etc.
- ELN, EBR, LIMS, MES preferred
- Knowledge of GxP, FDA 21 CFR Part 11, and EudraLex Annex 11 regulations.
- Understanding of GAMP 5 guidance.
- Lean six sigma experience.
- Familiarity with emerging technologies such as equipment automation and robotic process automation
PRECISION TECHNOLOGY precision-ts.com
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