| | 50% onsite required
Work Schedule: Mon-Fri(normal business hours) Must Haves: Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
Position Summary:
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement.
Duties/Responsibilities Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers.
Provide electronic systems operational support and troubleshooting to end user.
Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
Propose and implement improvements to electronic systems to optimize business process and improve efficiency. Collaborate with end users to develop business case.
Anticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives.
Anticipate and perform troubleshooting and problem solving independently.
Train and mentor others on electronic systems use and operation.
Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution.
Facilitate design, testing and subsequent deployment of solutions.
Support health agency inspection as equipment area subject matter expert.
Perform other tasks as required to support the electronic systems.
Qualifications
Specific Knowledge, Skills, Abilities:
Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
Ability to work in a fast-paced team environment, meet deadlines and prioritize work.
Advanced technical, problem-solving skills and logical.
Ability to communicate effectively with peers, department management and cross-functional peers.
Mentoring, coaching, influencing, negotiating and personnel interaction skills.
Education/Experience/ Licenses/Certifications:
Bachelor s degree required, preferably in science or related engineering field.
6 years of relevant work experience in LIMS, ELN and laboratory data analysis systems preferably in a regulated environment.
Knowledge of analytical and microbiological test methods and environmental monitoring programs preferred.
Demonstrated technical writing skills.
Demonstrated experience with validation and/or maintenance of laboratory information systems. |
