MI/OT QC Engineer

PRIMARY DUTIES

List primary job duties using action verbs (e.g., Performs, Coordinates, Administers, Manages, Directs, Oversees, Supervises, Leads, Facilitates, etc.). List duties in order of importance, consider percent of time spent on each activity and end result to be achieved.

1. This position requires experience in the installation, configuration, and administration of server, desktop, and lab instrument systems. This position requires the management of projects and externally sourced lab projects.

2. Conduct Failure Investigations and implement solutions (corrective and preventive actions) that solve MFG problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion.

3. The MI/OT Engineer executes project assignments from the beginning to successful completion and implementation with a minimum of direct supervision. The position is responsible for helping scope their specific roles in project as part scope, goals and deliverables to support business goals in collaboration with other members of the MI/OT team and project stakeholders.

4. The activities and projects will ensure that capacity needs are met and contribute to the enhancement of the Site's operational performance, through Cost / Quality / Safety.

5. dministration of: VMware systems, Ethernet networks, Windows Server and Desktop operating systems, Windows Active Directory, virtual backup and restoration systems, network storage devices, Cisco switches and imaging of thin-client terminals.

6. Provide support as a subject matter expert to maintain QC lab systems in a compliant and fit for intended use state.

7. Lead small projects and make independent decisions on operational technology problems.

8. Participate in commissioning and qualification activities (e.g. SAT, IQ, OQ) and conduct verification activities as required by the change control program.

9. nalyze computerized systems performance data to identify trends to predict potential failures and aid in solving product and process problems.

10. Review and revise Quality and Engineering documents for new and existing MFG systems.

11. This position will require some work to be done during non-standard work hours. Examples include, but are not limited to system crashes, infrastructure upgrades, hardware and/or software migrations, system validations, general maintenance activities, etc.

KNOWLEDGE, EXPERIENCE & SKILLS

Check the highest level education

required

(must be job-related). Identify the discipline, where applicable:

High School Diploma or GED

Master's Degree

Vocational/Technical

Doctorate

ssociate's Degree

Post Doctorate

Bachelor's Degree

Professional Certification

Will work experience be accepted in lieu of a degree? Yes No

If yes, number of years experience accepted in lieu of degree nd type:
Minimum of 5 years of hands on experience designing and administering computer systems and infrastructure
Minimum of 1 year of hands on experience with VMware VSphere
Minimum of 5 years of hands on experience with Windows desktop and server operating systems
Minimum of 4 years of hands on experience with Active Directory, including Group Policies
Minimum of 4 years of hands on experience with Cisco switch programming

List / describe specific work experience requirements and/or skills:

1. Minimum of 3 years of hands on experience designing and administering computer systems and infrastructure

2. Minimum of 3 years of hands on experience with Windows desktop and server operating systems

3. Minimum of 2 years of hands on experience with Active Directory, including Group Policies

4. Minimum of 2 years Cisco networking

5. Minimum of 1 year of hands on experience with VMware VSphere preferred

6. Experience working with integrators / outside contractors is preferred

7. Knowledge of cGMP, validation and FDA industry experience preferred

8. Strong ability to work in a team environment and independently.

9. Effective oral and written communication skills.
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