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Validation Scientist
3 months ago
Pay Range: $44.00-$53.00/hr (flexible based on years of experience)
Hours: Monday-Friday, 9:00am-5:00pm
Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year
Benefits: Medical, Dental, Vision and 401K plans available
Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Required Skills and Experience *
- Bachelors in Engineering, Science, IT, Robotics, or related field with 3-5 years of experience
- If Masters, 1-3 years of experience
- Strong interpersonal skills
- SOP development and review with focus on continuous improvement
- Direct experience with support of validation activities and all other associated Quality functions
- Understands regulatory and compliance requirements
- Root Cause Analysis skills
Knowledge of the details of automation including wiring, electrical, device selection and integrations
Nice to Have Skills and Experience
- Master's Degree
Job Description *
Our Bio-pharmaceutical Client is seeking a Automation Validation Scientist to join their team in West Point, PA. This individual will be a part of the Discovery, Preclinical and Translational Medicine Operations organization and will be responsible for supporting process automation systems in clinical and non-clinical Regulated Bioanalytic, Vaccine Modernization laboratories. This position may provide direct support to automation maintenance, system security, data management, obsolescence initiatives, and all SDLC and Compliance needs. They will work closely with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support. They will also be responsible for the successful implementation of Automation solutions, including both platform technologies and associated reporting needs as well as develop and complete appropriate system validation, Change Control and testing documentation. The Automation Validation Scientist will develop a suite of reporting, analytics and visualization solutions that support local clinical operations and administrative business processes; ensure automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with Current GXP requirements; And will be accountable for implementing system changes and conducting system investigations. They will have active and engaged participation in the routine operations support processes as well as supporting a culture of continuous improvement at the site. This will include trouble-shooting challenging equipment/automation issues to improve performance, engaging in vendor and IT support needs, responding to alarms, and implementing future AI/ML capabilities as available. They will be providing support or leading a small startup or existing production team providing technical assistance in fulfilling the automation requirements for the team and reviewing automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with GXP Practice and corporate safety requirements. In addition, they will be developing and supporting corrective actions for investigations related to automation systems, Using technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems and participating in compliance audits and training programs including providing client services support for business area laboratory applications
