Tittle: Engineer – PROQN 755
Location: Juncos, Puerto Rico
Work Schedule: Onsite – Administrative Shift
Schedule Flexibility: Must be available to work different shifts and/or weekends as business needs require
Positions Available: 1
Contract Duration: 6 months
Important Notice
This opportunity is available only to direct individual candidates. Third-party contractors, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.
Position Summary
Under general supervision, the Engineer will support process characterization, optimization strategies, and troubleshooting of operational issues within manufacturing, operations, pilot plant, and/or capital project environments.
The role applies fundamental engineering principles to the design and implementation of system modifications, experiments, and capital projects. The Engineer will also organize, analyze, and present results related to operational issues and engineering projects of limited to moderate scope and complexity.
Key Responsibilities
General Engineering Functions
Provide solutions to a variety of technical problems of moderate scope and complexity.
Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
Investigate assignments with clear and specific objectives involving a limited number of variables.
Initiate and complete routine technical engineering tasks.
Apply engineering principles to support troubleshooting, process optimization, and operational improvements.
Analyze and interpret technical data and communicate findings and recommendations.
Operations Engineering
Serve as a technical resource for equipment and systems, supporting operational troubleshooting and issue resolution.
Become actively involved in daily operations when necessary to meet schedules or resolve complex technical problems.
Audit the operational performance and regulatory compliance of equipment and systems of significant complexity.
Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for system modifications.
Support engineering activities related to pharmaceutical and biotechnology production processes, facilities, and equipment.
Provide technical support for operational issues and engineering initiatives.
Design Engineering & Capital Projects
Work under the direction of project managers to support design, engineering, and construction projects while maintaining schedule and budget requirements.
Collaborate with consultants, architects, and engineering firms in the development of standard design documents.
Obtain and evaluate vendor quotations for equipment modifications or installations.
Prepare basic project cost estimates and schedules.
Support capital projects and system modifications from an engineering perspective.
Coordinate with vendors and other project stakeholders as required.
Additional Responsibilities
Manage multiple tasks, projects, and priorities simultaneously.
Support engineering activities in a highly regulated pharmaceutical/biotechnology environment.
Perform other related functions as assigned.
Required Education & Experience
Master’s degree in Engineering, OR
Bachelor’s degree in Engineering with at least 2 years of Engineering experience.
Preferred Qualifications
Working knowledge of pharmaceutical and/or biotechnology processes.
Familiarity with validation processes.
Experience with documentation in a highly regulated environment.
Ability to operate specialized laboratory equipment and computers, as appropriate.
Ability to interpret and apply GLP and GMP requirements.
Ability to apply engineering principles and scientific knowledge to production environments.
Ability to develop solutions to routine technical problems of limited scope.
Strong problem-solving and applied engineering skills.
Basic technical report-writing skills.
Effective verbal communication skills.
Understanding of validation protocol execution requirements.
Basic technical presentation skills.
Strong personal organization and time-management skills.
Familiarity with validation protocol writing.
Ability to adapt to and manage change.
Technical knowledge related to equipment and systems.
Analytical problem-solving abilities.
Computer literacy.
What Would Make a Candidate Stand Out?
Candidates with the following experience or capabilities will be particularly valuable:
System Owner experience, including MMP experience.
Working knowledge and hands-on experience with cGMP procedures and engineering practices within pharmaceutical/biotechnology production processes, facilities, and equipment.
Experience using Maximo.
Experience creating and/or submitting Purchase Orders (POs).
Experience working with, coordinating, and escorting vendors.
Demonstrated ability to manage multiple tasks, projects, and priorities simultaneously.
Flexibility to support 24/7 operations, including occasional after-hours engineering coverage.
Ideal Candidate Profile
The ideal candidate will be an engineering professional who can work effectively in a regulated pharmaceutical or biotechnology environment, troubleshoot equipment and operational issues, and collaborate with cross-functional teams. Strong organizational skills, analytical problem-solving, and the ability to manage multiple priorities are important for success in this role.
Schedule flexibility is also important, as the position may require support outside of the regular administrative schedule based on operational needs.