QA Validation Analyst/Engineer II

Validation & Engineering Group; Carolina (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a QA Validation Analyst/Engineer II to plan and approve validation tasks across manufacturing processes, equipment, and information systems.

Under the Validation Section Manager, you will perform validation activities and contribute to quality program deployment at the plant. The role requires experience in validation investigations, SOP review, CAPA integration, and supporting regulatory audits.

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 2+ years of experience in Manufacturing, Quality or Engineering.
• Fully bilingual English/Spanish with excellent oral skills.

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.
• Ensure investigations of validation failures are thorough and documented in the CAPA system when required.
• Collaborate with plant and external resources on new installations/systems to ensure cGMP compliance.
• May supervise contract validation resources.

Skills

Kaye Validator

TempTales

Temperature/RH mapping

Equipment/Utilities Validation

CIP/SIP Validation

Education

Bachelor's degree in Biology, Chemistry or Engineering

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?

1. Proficiency using Kaye Validator and TempTales to perform temperature mapping studies.
2. Qualification / Validation of temperature/RH controlled chambers (temperature/RH mapping for freezers, incubators, cold rooms, refrigerators, ect.)
3. Experience completing Equipment/ Utilities/Facilities Validation Periodic Reviews, including evaluation or Risk Assessments.
4. Sterilization cycles qualifications for autoclaves and Steam In Place (SIP).
5. 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. 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.