Engineer-31979, 32130, 31981 (N22)

BioPharma Consulting JAD Group has several Senior Associate Tech Engineering positions open with an industry leader working on site in Juncos, Puerto Rico. This is a temporary position with the possibility of extension.

Job Details:

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
3. Assistance given for unusual problems
4. Perform assignments that have clear and specific objectives and require investigation of limited number of variables
5. 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 degree in Engineering & 2 years of Engineering
  
  *Specific background should be Chemical Engineering, Mechanical Engineering or Electrical Engineering.

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
• Experience in drug substance/API operations
• Preferred experience in equipment start up, troubleshooting, PLC
• Candidate must be able to understand manufacturing equipment, failure modes and troubleshoot equipment (valves, pumps, utilities systems)

Demonstrated skills in the following areas:

• Problem solving and applied engineering
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements
• Basic technical presentations
• Personal Organization
• Validation Protocol Writing
• Dealing with and managing change
• Technical (Equipment Specific)
• Analytical Problem Solving
• Computer Literacy
• Available for following shift: 5pm to 5:30am

Requirements

Our 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, the company 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 the company, its operations, or its staff.