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Jr Engineer (Commissioning & Qualification)

New Albany, OH
Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.
DESCRIPTION
In charge of the C&Q of the equipment assigned as well as shall be directly accountable to and coordinate all of their activities through the Functional Area Leads (FAL). Commissioning engineers will support such activities as:  CMMS Development, Mechanical Completion Walkdowns, Punchlist Generation/close-out, Field Turnover Package Review, Set to Work (STW), Installation Verification (IV), Automation Check Out (ACO), Site Acceptance Testing (SAT), Function Testing (FT), Engineering Change Management, Qualification Summary Reporting

EDUCATION
Master’s degree or Bachelor’s degree in Engineering and 2-3 years of Engineering experience.


RESPONSIBILITIES
  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
  • Initiate and complete routine technical tasks.
  • 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.
  • Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
  • Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
  • Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
  • Work with consultants, architects and engineering firms on development of standard design documents.
  • Obtain and critique quotes for equipment modifications or installations. Generate rudimentary project cost estimates and schedules.


REQUIREMENTS/SKILLS
  • Working knowledge of pharmaceutical/biotech processes
  • Familiarity with validation processes and requirements as applied to new equipment installations
  • Knowledge in Packaging equipment.
  • Ability to lead troubleshooting initiatives for equipment and operational issues.
  • Experience defining, managing and documenting equipment related changes.
  • Excellent interpersonal and time management skills to manage changing priorities from multiple stakeholders
  • 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:
o Problem solving and applied engineering.
o Basic technical report writing
o Verbal communication
  • Comprehensive understanding of validation protocol execution requirements.
  • Demonstrated Skills in the following areas:
o Basic technical presentations
o Personal Organization
o Validation Protocol Writing
o Dealing with and managing change
o Technical (Equipment Specific)
o Analytical Problem Solving
o Computer Literacy


Ultimate Solutions Corp is an Equal Opportunity Employer.


 

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