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. Administration 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. Analyze 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

Associate'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 and 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.

SUPERVISORY RESPONSIBILITIES

N/A

Direct supervision (approximate) ____ total employees supervised

Indirect supervision (approximate) ____ total indirectly supervised

IMPACT / MANAGEMENT SCOPE

Decision making or problem solving authority: None Basic Significant

Describe empowerment, decision making, and problem solving authority.

The authority to solve problems with solutions that do not extensively alter the configuration or structure and do not violate the validated state.

Check appropriate decision making authority below:

Decisions with long term impact

Decisions with short term impact

With little to no supervisory review

With little to no supervisory review

With supervisory review/approval required

With supervisory review/approval required

If applicable, please include the following:

Revenue Size: N/A

Sales Volume: N/A

Operating Budget: N/A

WORKING CONDITIONS

Domestic travel require __5__ % of time International travel required _0__ % of time

Typical office setting

Home-based

Manufacturing/Operations Center

Laboratory with exposure to chemicals

Physical Requirements – Enter % of time for each applicable category:

Activity

Not Applicable

5-10 lbs

10-25 lbs

25-50 lbs

50-100 lbs

100-150 lbs

150+ lbs

Lifting

10%

10%

1%

Pushing

10%

10%

1%

Pulling

10%

10%

1%

Physical Requirements – Enter % of time for each applicable job activity:

Activity

Percent of Time (if applicable)

Other:

Bending

5%

(Please describe):

Walking

10%

Standing

15%

Sitting

60%

Typing

30%