Primary IT resource supporting GxP applications and systems in accordance with 21 CFR Part 11 and GAMP 5. This role will be hands-on and highly cross-functional working closely with various business groups who work with GxP systems.
* Collaborate with scientists, instrument vendors, quality personnel, and IT colleagues to implement and support GxP systems in a controlled laboratory and manufacturing environment.
* Provide support during new systems implementation, overseeing design, development, or configuration to ensure the solutions will meet business needs while adhering to IT policies and procedures, compliance standards, and GxP requirements.
* Participate in GMP validation activities including the execution of IQ/OQ/PQ testing; assist with creation of test scripts as required. Perform integration and system level tests and execute any necessary supporting documentation.
* Assist with change control impact assessments for GxP systems changes.
* Conduct Periodic Reviews to confirm computerized systems are compliant with company procedures and regulatory agency requirements.
* Provide Tier 1-2 IT operational support for GxP lab environments.
* Manage and troubleshoot laboratory software with vendor support, as needed
* Consult with Quality and IT Management to resolve complex issues in a timely manner.
* Coordinate with and manage vendors to ensure the latest software versions are compatible with systems.
* Assist with inventory management of instrument-connected computers and broker preventive maintenance/calibration of specialized equipment not under service agreements with external vendors.
* Collaborate with the IT team to support hardware, software, and infrastructure needs for GxP systems. Deliver to best practices in IT architecture, IT security, and GxP compliance.
* Propose alternate processes and procedures to streamline and increase effectiveness and efficiency of IT operations.
* Research and establish test and control policies and procedures that protect the network/systems environment from failures.
* Collaborate on projects that help bring in new technologies or enhance old ones for the lab.
* 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.)
* Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
* Other duties as assigned
Experience / Education:
* 3 years of hands on experience maintaining quality control of an IT environment
* 2 years of experience supporting GxP laboratory applications and systems
* Bachelor's Degree in Computer Science, Computer Information Systems (CIS), or related field
* Understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Change ControlWorking knowledge of Active Directory/LDAP and Windows Security
* Experience with one or more of the following: software testing and deployment, user access review, asset lifecycle management, and data archival and backup strategies
* Knowledge of laboratory automation technologies such as electronic laboratory notebooks, lab or manufacturing execution systems, LIMS, chromatography systems, etc.
* Detail-oriented with problem solving, analytical, and critical thinking skills
* Excellent collaboration and communication skills
* Ability to manage competing priorities and flexibility to shift work load when needed
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.