Technical Engineering Specialist

Job Title: Technical Engineering Specialist

Location: East Region, Puerto Rico

Schedule: Hybrid work on Administrative Shift

Duration: Approximately Six (6) Months

Positions Available: 1

Summary:

We are seeking a Technical Engineering Specialist to provide hands-on technical support for system and equipment optimization, upgrades, replacements, and modifications. The role ensures maintenance operations align with corporate policies, industry regulations, and FDA compliance standards.

Key Responsibilities:

• Ensure utility, process maintenance, instrumentation, calibration, electrical, and technical cleaning systems comply with regulatory and FDA standards.
• Maintain training programs, SOPs, and equipment/system operational standards within the maintenance team.
• Provide technical guidance to the maintenance team on engineering, compliance, calibration, and validation issues.
• Support FDA and other regulatory inspections and responses.
• Address high purity water systems and environmental monitoring alert/action notifications.
• Conduct and support investigations and audit programs for compliance assurance.
• Collaborate with Plant Engineering to evaluate and implement system/process improvements.
• Propose process, utility, and cleanroom system modifications to the Plant Engineering Group.
• Review and improve sanitization and maintenance procedures.

Preferred Qualifications:

• Strong organizational skills
• Experience with MAXIMO data entry
• Familiarity with job plans, data sheets, and engineering drawings

Education Requirements:

• Doctorate degree OR
• Master’s degree with 3 years of Engineering experience OR
• Bachelor’s degree with 5 years of Engineering experience OR
• Associate’s degree with 10 years of Engineering experience OR
• High school diploma/GED with 12 years of Engineering experience

Key Competencies & Skills:

• Leadership and teambuilding
• Strong verbal and written communication
• Technical writing and documentation
• Change management and facilitation
• Validation protocol knowledge
• Analytical and technical problem-solving
• Project planning and scheduling
• Computer literacy

If you meet the qualifications and are interested in joining a dynamic team committed to excellence, we invite you to apply using the job description link and submit your updated resume.