Quality Validation Engineer

International Association of Plumbing and Mechanical Officials (IAPMO); Allentown, Northern (Lehigh County, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

IAPMO is seeking a Quality Validation Engineer to lead validation activities across packaging, laboratory and utility systems in Allentown, PA. The role involves planning, executing, and documenting installation and qualification studies, ensuring regulatory compliance and coordination with process heads and engineering teams.

The ideal candidate will have 4+ years in validation or regulatory roles, a scientific/technical degree, strong project management skills and a meticulous attention to

Qualifications

• Bachelor’s degree or higher in relevant scientific/technical field.
• Total Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience.
• Experience in project management.
• Well organized with keen attention to detail.
• Knowledge of the various state and federal pharmaceutical validation laws and legislations.

Responsibilities

• Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems.
• Schedules, plans, manages and executes studies for cleaning validation.
• Schedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocol.
• Reviews and approves validation project documentation.
• Coordinates with process unit heads, quality and engineering groups to ensure successful project execution.
• Leads and coordinates cross-functional teams for project validation.

Skills

cGMP & regulatory compliance

professional communication

computer literacy

collaboration

project management

Education

Bachelor's degree or higher in a scientific/technical field

Tools

Microsoft Outlook

Excel

Word

Job description

Quality Validation Engineer

Essential Duties and Responsibilities

• :Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility system
• sSchedules, plans, manages and executes studies for cleaning validation
• sSchedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocol
• sReviews and approves validation project documentatio
• nCoordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project execution
• sLeads and coordinates cross-functional teams for project validatio
• nPriorities, manages and executes multiple projects utilizing the project management methodologie
• sOversees external validation resource
• sSupports the development of best and proven validation practices in the validation department based on current industry guidelines and practice
• sAuthors relevant standard operating procedures for ensuring compliance with the company’s policie
• sSupports regulatory submissions and also regulatory agency inspections whenever requeste
• dChampions continuous improvements in the validation departmen

tKey Competencies (knowledge, skills and abilities every person must possess to be successful

• )cGMP and Regulatory Compliance - Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organisatio
• nProfessional Communication - Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority level
• sComputer Literacy - Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based system
• sCollaboration - Utilize teamwork and problem solving skills across all departments and internally to Quality Assuranc
• eProject Management - The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manne

rEducation / Experienc

• eBachelor’s degree or higher in relevant scientific/technical fiel
• dTotal Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience preferre
• dExperience in project managemen
• tMust be well organized with a keen attention to detai
• lKnowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to tim