QA Validation Analyst/Engineer II

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a QA Validation Analyst/Engineer II to drive validation activities and ensure regulatory compliance at the plant level.

Responsibilities include planning, reviewing documentation, and leading investigations while working under minimal supervision in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 2+ years of Manufacturing, Quality or Engineering experience preferred.
• Strong communication and problem-solving skills.
• Fluent in English and Spanish; good written/spoken skills.
• Willingness to work extended hours including weekends/holidays.

Responsibilities

• Participate in implementation and maintenance of the Quality System to meet regulatory requirements.
• Ensure practices and procedures comply with policies and regulations for Quality areas.
• Execute tasks to implement the Validation Master Plan and maintain validated state of equipment, utilities, facilities, and processes.
• Investigate validation failures and document root causes, contributing to CAPA system.
• Collaborate with plant/external resources on new installations/systems to align with cGMP and validation.
• May supervise contract validation resources to ensure timely completion.

Skills

Verbal and written communication

Problem solving

Analytical skills

Interpersonal skills

Negotiation skills

Bilingual English/Spanish

Education

Bachelor's degree in Biology, Chemistry or Engineering

Tools

Kaye Validator

TempTales

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:

• QA Validation Analyst/Engineer II

Description

The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level.

The Validation Engineer responsibilities may include: the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance routines, set-up of laboratory samples for qualification, participation in the establishment of plant quality systems, supporting regulatory and third party audits.

Responsibilities

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.
• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
• Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering.
• Prefer 2+ years of overall experience in Manufacturing, Quality or Engineering.
• Good verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Good negotiation skills.
• Prefer knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Available to work extended hours, possibility of weekends and holidays.

What are the top 3-5 skills, experience or education required for this position?

• Proficiency using Kaye Validator and TempTales to perform temperature mapping studies.
• Qualification / Validation of temperature/RH controlled chambers (temperature/RH mapping for freezers, incubators, cold rooms, refrigerators, ect.)
• Experience completing Equipment/ Utilities/Facilities Validation Periodic Reviews, including evaluation or Risk Assessments.
• Sterilization cycles qualifications for autoclaves and Steam In Place (SIP).
• Cleaning Validation for Clean In Place (CIP) and automated washer equipment.

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.