DifGen Pharmaceuticals

Validation Technician

DifGen Pharmaceuticals  •  $65k - $70k/yr  •  Miramar, FL (Onsite)  •  11 days ago
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Job Description

Job Location: Miramar, FL 33025,

Salary Range: $65,000.00 - $70,000.00 Salary/year,

Job Shift: Day,

  • Job Description
  • Job Title (Internal)
  • Validation Technician
  • Job Profile/Level:
  • One level below Validation Engineer
  • Line of Business (LOB) or Business Process Stream (BPS)
  • Operations / Validation
  • Department/Org Unit:
  • Validation Engineering
  • Reports Directly To:
  • Validation Manager
  • Reports Indirectly To:
  • Associate Director Technical Services and Validation
  • People Leader
  • No
  • Number of Direct Reports and Job Titles
  • None
  • Revision Date
  • (Month / Day / Year)
  • 08/12/26
  • Revision Number:
  • 1

Job Location

  • Aveva, Miramar
  • Travel Requirements
  • Yes (only between budlings/sites)

Qualifications: Job Summary

The Validation Technician supports Cleaning Validation, Process Validation, and Commissioning & Qualification (C&Q) for pharmaceutical manufacturing operations to ensure compliance with cGMP requirements, approved procedures, validation plans, and applicable regulatory requirements.

The role primarily supports the execution and maintenance of validation programs, including protocol generation and execution, validation data entry, data collection and review, equipment and process monitoring, documentation of results, report preparation, and support of validation lifecycle activities.

The Validation Technician works under the direction of Validation Engineers and Validation Management and collaborates with Manufacturing, Quality, Engineering, Quality Control, Microbiology, and other cross-functional departments to ensure validation activities are completed accurately, efficiently, and in accordance with approved requirements.

Job Responsibilities

  • Assist in the execution of Cleaning Validation, Process Validation, and Commissioning & Qualification (C&Q) protocols and activities, as applicable, for manufacturing equipment, processes, utilities, and systems.
  • Collect, organize, and analyze validation data and support the preparation of validation documentation, including reports, protocols, and deviations.
  • Perform routine testing and monitoring of equipment and processes to ensure compliance with validation requirements.
  • Support troubleshooting and investigations related to validation deviations, failures, and out-of-specification results.
  • Assist in preparing for regulatory inspections, audits, and customer visits by providing validation documentation and records as required.
  • Support continuous improvement activities by identifying areas for optimization in validation processes and procedures.
  • Maintain validation files, records, and databases in an organized manner to ensure traceability and compliance.
  • Adhere to all safety, quality, and compliance requirements, including cGMP, SOPs (Standard Operating Procedures), and validation protocols.
  • Collaborate with Validation Engineers, Production, Quality Control, and other departments to ensure timely completion of validation activities.
  • Operate in accordance with the company's Code of Conduct and Business Ethics and all established regulatory compliance and safety requirements.
  • Perform all work in support of the company’s values: Collaboration, Courage, Perseverance, and Passion.
  • Perform other relevant duties as assigned.

Knowledge, Skills and Abilities

  • Basic understanding of validation principles, including Cleaning, Process, C&Q, and cGMP requirements.
  • Basic knowledge of pharmaceutical manufacturing processes and equipment.
  • Strong organizational and time management skills.
  • Excellent attention to detail and ability to work accurately under pressure.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with validation software or databases.
  • Ability to work independently and as part of a team in a fast-paced environment.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively across departments.
  • Strong technical writing and documentation skills, with the ability to prepare clear, accurate, and compliant validation protocols, reports, and other technical documentation.
  • Basic troubleshooting skills for validation equipment and processes.
  • Ability to read and interpret technical documents, including SOPs, validation protocols, and engineering drawings

Education

  • An associate or bachelor’s degree in a relevant field, such as life sciences, engineering, chemistry, or a related discipline, is preferred; or relevant validation experience.

Experience

  • Minimum of 1 - 3 years of experience in a pharmaceutical manufacturing environment or similar regulated industry.
  • Experience in supporting validation activities, including protocol execution and documentation preparation (preferred).
  • Approvals
  • People Leader:
  • Jessica L. León
  • Manager, Validation
  • Print Name
  • Job Title
  • Signature
  • Date
  • Employee:
  • Print Name
  • Employee number
  • Signature
  • Date

Note: The People Leader is responsible for saving a PDF of all signed and true job descriptions for their direct reports.

DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
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