Job description

Requirements Education & Experience

Master’s degree OR

Bachelor’s degree in Engineering AND 2 years of Engineering experience

shift: 8hrs shift | 1st

Preferred Qualifications

· Excellent written and verbal communication skills.

· Technical writing experience

· Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.

· Experience with change control, nonconformance, corrective and preventative actions, and validation practices.

· Experience with Maximo

· Capable of working and/or submitting Purchase Orders (PO)

· Experience working and escorting vendors.

· Capable of handling multiple tasks, projects and/or priorities at the same time

· Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.

· Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Description:

Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.

SUMMARY

Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

FUNCTIONS

1. Provide solutions to a variety of technical problems of moderate scope and complexity.

2. Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.

3. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. (*)

4. Initiate and complete routine technical tasks.

Operations Engineering:

1. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. (*)

2. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. (*)

3. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. (*)

Design Engineering:

1. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. (*)

2. Work with consultants, architects, and engineering firms on development of standard design documents. (*)

3. Obtain and critique quotes for equipment modifications or installations.

4. Generate rudimentary project cost estimates and schedules.

* Other functions may be assigned

EDUCATION

Master’s degree OR Bachelor’s degree in Engineering & 2 years of Engineering experience

PREFERRED QUALIFICATIONS

· Working knowledge of pharmaceutical/biotech processes

· Familiarity with validation processes

· Familiarity with documentation in a highly regulated environment

· Ability to operate specialized laboratory equipment and computers as appropriate.

· Ability to interpret and apply GLPs and GMPs.

· Ability to apply engineering science to production.

· Able to develop solutions to routine technical problems of limited scope.

Demonstrated skills in the following areas:

· Problem solving and applied engineering.

· Basic technical report writing

· Verbal communication

· Comprehensive understanding of validation protocol execution requirements

Demonstrated Skills in the following areas:

· Basic technical presentations

· Personal Organization

· Validation Protocol Writing

· Dealing with and managing change

· Technical (Equipment Specific)

· Analytical Problem Solving

· Computer Literacy.

1st Shift

Job Type: Contract

Schedule:

• 8 hour shift
• Weekend availability

Work Location: One location

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