Enter a job title or keyword
Process Engineering Specialist
Job Location:
Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not provided by the employer
Monthly Salary:
Experience Required:
4years
Experience Required:
Posted:
24 May 2026 (30+ days ago)
Posted:
Application Deadline:
21 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
The Process Engineer is responsible for ensuring the reliability compliance and performance of manufacturing processes equipment utilities and computerized systems within a pharmaceutical or biotechnological environment. This role requires strong expertise in process engineering computer system validation and technical troubleshooting supporting daily operations and continuous improvement initiatives to maintain regulatory compliance and operational excellence.
- Provide daytoday troubleshooting for manufacturing equipment automated systems utilities and process deviations to ensure uninterrupted operations.
- Lead and execute the Computer Validation Life Cycle (CVLC) for systems such as SCADA PLCs smart instruments and networked control systems.
- Develop and execute FAT IQ OQ and PQ protocols including preparation of qualification reports and supporting documentation.
- Prepare and maintain SOPs disaster recovery plans backup strategies and system configuration documentation.
- Conduct Quality Risk Assessments and Qualification Risk Assessments for equipment utilities and computerized systems.
- Support and manage engineering and validation activities for facility expansions new equipment installations and system upgrades.
- Perform commissioning startup and qualification of critical utilities including HVAC compressed air purified water systems and facility infrastructure.
- Participate in investigations CAPA development and root cause analysis for process equipment and system failures.
- Review engineering drawings P&IDs material certifications welding documentation and construction packages for compliance and technical accuracy.
- Collaborate in HAZOP hazard analyses and safety assessments for new and existing systems.
- Develop and maintain Calibration Programs HEPA filter certification processes and software control systems.
- Prepare Validation Master Plans analytical reports and regulatory documentation to support audits and inspections.
- Work closely with crossfunctional teams including Manufacturing Quality Assurance Engineering and Automation to ensure process robustness and compliance.
Requirements
- Bachelors degree in Engineering (Chemical Mechanical Electrical Industrial Biomedical or related field).
- Demonstrated experience in oral solids manufacturing processes specifically tablets.
- Previous experience in handling problem solving and research associated with tablet manufacturing equipment and processes (mixing compression coating compaction in Roller Compactor)
- Extensive experience in process engineering validation metrology and quality assurance within pharmaceutical or biotech manufacturing.
- Strong knowledge of 21 CFR Part 11 GAMP and validation of automated systems (SCADA PLCs HVAC water systems utilities).
- Demonstrated ability to perform technical troubleshooting on equipment and computerized systems.
- Experience with investigations deviations and CAPA management.
- Experience in project management facility startups equipment commissioning and system upgrades.
- Proficiency in developing protocols SOPs risk assessments and validation documentation.
- Strong communication teamwork and leadership skills.
Required Skills:
Bachelor in Engineering or Sciences At least five years or experience with regulated industries Bilingual (Spanish/English)(Written and spoke) Exposure to regulated industries Technical writing
