Manage day-to-day System Administration, user support and implementation of GxP Computerized Systems in QC Analytical Lab Manufacturing and other regulatory operations including, but not limited to, networked and nonnetworked standalone instruments, firmware based instruments, HMI's, SCADA systems and any GxP application software at any manufacturing site across the North America region.
Area of Responsibility - Collaborate with business partners in various functions, instrument vendors, and other IT team members to implement, perform applications administration and support GxP applications and systems in a controlled laboratory, manufacturing and other regulatory functions. This includes, but not limited to maintaining GxP Systems Inventory, User Access Management - activation, modification and deactivation of users, managing user access privileges, implementation and/or retirement of GxP systems, ensuring that Backup of all GxP systems is being taken, Recovery of GxP systems when required and any other related activity assigned by IT Management through application of cGMP principles and following internal standard operating procedures (SOPs), work instructions (WIs), and regulatory requirements. ?
Provide support during new systems implementation, overseeing design or configuration and validation (IQ / OQ/ PQ) to ensure the solutions will meet business needs while adhering to IT policies and procedures, compliance standards, and GxP requirements.
Conduct Periodic Reviews such as but not limited to User Access Management, Systems Validation Reviews, SOP Reviews etc. to confirm computerized systems are compliant with company procedures and regulatory agency guidelines and requirements.
Assist with QMS processes within IT, especially change control impact assessments, CAPA execution and managing deviations and incidents through root cause analysis for GxP systems changes.
Propose alternate processes, procedures and process automation pathways to streamline and increase effectiveness and efficiency of IT operations.
Collaborate with various stakeholders globally and/or across the sites within the region to understand and implement best GxP IT practices.
Support regulatory, customer and other such audits from IT department. Work
Conditions:
Manufacturing/Production/Laboratory environment Environmental related to manufacturing/production/laboratory environments:
Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
Odors: Unpleasant smells.
Gases: Examples include carbon monoxide and helium.
Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts.
Physical Requirements:
Able to lift and carry up to 50 lbs. while performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms.
The employee is occasionally required to stand, stoop, kneel and crouch. Specific vision abilities required of this job include close vision, distance vision, color vision and the ability to adjust focus. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Travel Estimate Up to 25% to other sites within North American geography and sometimes for vendor audits
Education and Job Qualification
Minimum of a Bachelor's Degree. Preference will be given to a candidate having a bachelor's degree in Life Sciences, Pharmacy, Computer Science or Computer Information Systems (CIS) or related field.
Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System.
Excellent collaboration and communication skills.
Ability to manage competing priorities and flexibility to shift workload when needed.
Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
A team player with ability to work with people at all levels and diverse skill sets. Requires travel for up to 25%-30% of the work hours.
Experience: Minimum 6-7+ years of hands on experience maintaining, administering GxP systems, applications, instruments and shop floor machines in a manufacturing and/or quality function with detail orientation and strong problem solving, analytical, and critical thinking skills.
MUST HAVE
Ø Minimum of 3 years GxP (fundamental and conceptual)
Ø Empower3, lower version acceptable Experience with Empower 3 is preferred. There is also general system admin backup support for the other locations.
Keywords Waters, Perkin Elmer, Mettler Toledo)
**good with applications (vs.. networking or infrastructure)
Lab experienceWe are Manufacturing (vs Clinical)
Applications experience vs. network
i.e Veeva, Kneat, LeanIX, ServiceNow,Empower TrackWise, LIMS, Maximo, and MODA