RCI-ABBV-35297 Validation Engineer / Validation Specialist (Temperature Mapping/IQ/OQ/PQ)

Rangam; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Rangam is seeking a Validation Analyst Engineer II to support validation and compliance in a biopharma manufacturing environment, focusing on temperature-controlled systems, equipment validation, and rigorous documentation of protocols and reports.

Under the Validation Section Manager, you will execute validation activities, author and review protocols and summary reports, conduct revalidations, and collaborate with operations to minimize downtime while maintaining cGMP standards.

Qualifications

• Bachelor’s degree in engineering or related scientific field.
• 2+ years of validation/quality experience in pharma/biopharma.
• Strong hands-on experience with Kaye Validators and TempTales.
• Experience validating temperature-controlled environments and equipment.
• Excellent technical writing for protocols and reports.
• Solid GMP knowledge and regulatory awareness.

Responsibilities

• Participate in implementation and maintenance of the Quality System.
• Execute validation activities and maintain equipment/utilities in a validated state.
• Review investigations and support CAPA related to validation.
• Collaborate with plant and external resources for new installations.
• Supervise contract validation resources as needed.

Skills

Kaye Validators

TempTales

Temperature mapping

Equipment validation (EF&U)

Technical writing

GMP knowledge

Execution & documentation

Education

Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related)

Tools

OSI PI / DeltaV

Vault

Job description

Validation Analyst Engineer II responsible for supporting validation and compliance activities in a biopharma manufacturing environment. The role focuses on temperature-controlled systems, equipment validation, and documentation, ensuring compliance with GMP standards. The candidate will handle both execution and documentation (protocols & reports) related to validation activities.

Manager's Update

• Perform validation activities for temperature-controlled equipment such as Autoclaves, Refrigerators, freezers, cold rooms, Incubators and controlled chambers
• Execute and generate Validation protocols, Summary reports and final documentation
• Conduct periodic revalidation of equipment and systems
• Support validation for Bioreactors, Chromatography skids, Filtration systems, Portable tanks
• Utilize tools like Kaye Validators and TempTales for temperature mapping
• Perform troubleshooting and ensure compliance with validation standards
• Collaborate with operations teams to schedule validation activities and minimize downtime
• Work within GMP guidelines and ensure proper documentation in systems
• Bachelor’s degree in Engineering (Chemical, Mechanical, Biomedical, or related) Or relevant scientific discipline
• Pharma or Medical Device background with GMP experience

Must-Have Skills

• Strong hands-on experience with Kaye Validators and TempTales (critical), Temperature mapping of controlled environments
• Experience in equipment validation (EF&U – Equipment, Facilities & Utilities)
• Strong technical writing skills (protocols & reports)
• Knowledge of GMP environment (mandatory)
• Ability to perform both Execution of validation, Documentation & reporting

Required Experience

• 3–5 years of experience in validation within pharma/biopharma
• Experience in Temperature-controlled systems
• Exposure to GMP-regulated environments (mandatory)

Preferred Skills

• Experience with SIP (Sterilization-in-Place) (nice to have)
• Basic understanding of CIP (Cleaning-in-Place)
• Exposure to Biopharma processes (bulk drug substance & drug product)
• Basic project management skills (planning, coordination with operations)
• Familiarity with systems (nice to have, not mandatory) OSI PI / DeltaV (data collection), Vault (document management)

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
• BA Sciences
• 3-5 Years of experience

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:

List up to 10 main responsibilities for the job. Include information about the accountability nd

scope.

• 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:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• 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
• Prefer knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Daily Work Schedule Expectations

• Monday to Friday 8-5

Is overtime offered or required?

• Candidates must be flexible to support validation activities and available different schedules based in business needs – will be notify with anticipation