Engineer

Pinnaql; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. (a Pinnaql company) seeks a talented engineer to support regulated pharma/biotech operations, troubleshoot equipment and processes, and drive continuous improvement.

Requirements include a Master or Bachelor in Engineering and 2 years of experience, with GMP knowledge and strong English/Spanish communication. Non-standard 12-hour shifts, including nights and weekends, are required.

Qualifications

• Experience with equipment and process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Organizational and technical writing skills.
• Proficient presentation and communication skills in English and Spanish.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques under supervision.
• Serve as technical expert to process, equipment, and systems during troubleshooting.
• Participate in daily operations to meet schedules and resolve complex problems.
• Supervise manufacturing processes for performance indicators and provide troubleshooting mentorship.
• Collaborate with manufacturing, maintenance, QA and validation to develop requirements for modifications.
• Support deviations, equipment qualification, process validation and training.

Skills

Troubleshooting in regulated env.

GMP knowledge

English/Spanish communication

Technical writing

Education

Engineering degree (Master or Bachelor)

Mechanical/Electrical/Chemical background

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Non standard 12 hrs Shifts: 2/3/2 days shift
  • Example: Week 1: ( Mon-Tues (12hrs shift)) / Fri-Sat-Sun (12 hrs shift) Week 2: Wed-Thurs

Education::

• Master degree OR Bachelor degree in Engineering & 2 years of Engineering experience.
• Educational background in Mechanical, Electrical and/or Chemical Engineering

Experience::

• Experience with equipment and/or process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Organizational & technical writing skills.
• Proficient presentation & communication skills in English and Spanish

Attributes:

• This role the resources will provide technical engineering support to continuous daily operations by performing troubleshooting activities, process optimization strategies, upgrades, replacements, and modifications to the process or equipment in the manufacturing operations.
• Ensure that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.
• This role will support non-standard shift manufacturing operations that may nights and weekends.

Specific responsibilities include but are not limited to:

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures. Assistance given for unusual problems.
• Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
• Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
• Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
• Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
• Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
• Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
• Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
• Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.