Engineer- PRQN 778
ProQualityNetwork
Job Description
Job Description
Tittle: Engineer – PRQN 778
Location: Juncos, Puerto Rico
Work Schedule: Onsite | Administrative Shift, 8:00 AM–5:00 PM
Contract Duration: 6 Months
Positions Available: 1
Schedule Flexibility
The selected candidate must be available to work different shifts, including extended hours, nights, weekends, and holidays, based on business needs.
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 provides support for process optimization, characterization strategies, and troubleshooting of operational issues within operations, manufacturing, pilot plant, and capital project environments.
The Engineer applies fundamental engineering principles to the design and implementation of system modifications, experiments, and capital projects. This role also organizes, analyzes, and presents results related to operational issues and engineering projects of limited scope and complexity.
Key Responsibilities
General Engineering
- 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 involving a limited number of variables and clearly defined objectives.
- Initiate and complete routine technical engineering tasks.
- Apply engineering principles and technical knowledge to support manufacturing and operational activities.
- Develop solutions to routine technical problems within established guidelines.
Operations Engineering
- Serve as a technical resource for equipment and systems, particularly in troubleshooting operational issues.
- Become actively involved in daily operations when needed to meet schedules or resolve complex technical problems.
- Routinely audit the operational performance and regulatory compliance of equipment and systems of moderate quantity and 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 production operations and process improvements.
Design Engineering
- Work under the direction of project managers to support design, engineering, and construction projects while meeting schedule and budget requirements.
- Collaborate with consultants, architects, and engineering firms in the development of standard design documentation.
- Obtain and evaluate quotations for equipment modifications, installations, and related engineering work.
- Prepare basic project cost estimates and schedules.
- Support engineering projects from planning through implementation as required.
Other functions may be assigned based on business needs.
Required Education
- Master’s degree in Engineering , OR
- Bachelor’s degree in Engineering with at least 2 years of engineering experience.
Preferred Qualifications
The following qualifications and experience are preferred:
- Working knowledge of pharmaceutical or biotechnology processes.
- Experience in biotechnology processes, particularly purification operations .
- Knowledge of chromatography and UF/DF (Ultrafiltration/Diafiltration) techniques .
- Familiarity with validation processes.
- Familiarity with technical documentation within a highly regulated environment.
- Ability to operate specialized laboratory equipment and computer systems, as applicable.
- Ability to interpret and apply GLP and GMP requirements.
- Ability to apply engineering principles and scientific knowledge to production operations.
- Ability to develop solutions to routine technical problems of limited scope.
- Strong problem-solving and applied engineering skills.
- Basic technical report-writing skills.
- Strong verbal communication skills.
- Understanding of validation protocol execution requirements.
- Basic technical presentation skills.
- Strong organizational and time-management skills.
- Experience with validation protocol writing.
- Ability to adapt to and effectively manage change.
- Technical knowledge related to equipment and systems.
- Analytical problem-solving skills.
- Computer literacy.
Ideal Candidate Profile
Candidates who have hands-on experience supporting biotechnology manufacturing and purification operations will be particularly well suited for this opportunity. Experience with chromatography, UF/DF, equipment troubleshooting, validation activities, and GMP-regulated environments is highly desirable.
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