Description

Qualifications

Job Responsibilities

• Assist in the execution of validation protocols (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)) 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.
• Participate in the calibration and maintenance of validation equipment and ensure all equipment is in a qualified state.
• 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.

Job Requirements

• Education
• An associate degree or a bachelor’s degree in a relevant field such as life sciences, engineering, chemistry, or a related discipline.  Or 5 to 7 years of relevant experience in commissioning & qualification, or computer system validation or cleaning validation or process validation.

• Knowledge, Skills and Abilities

• Basic understanding of validation principles, including IQ, OQ, PQ, and cGMP requirements.
• 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.
• Basic troubleshooting skills for validation equipment and processes.
• Ability to read and interpret technical documents, including SOPs, validation protocols, and engineering drawings.

• Experience

•  Minimum of 2 years of experience in a pharmaceutical manufacturing environment or similar regulated industry.
• Experience in supporting validation activities, including protocol execution and documentation preparation (preferred).

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

Salary : $30 - $32