QA Validation Engineer

About the role

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We deliver critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all stakeholders. PCC maintains a wide presence across the US, Europe, and more than 100 countries, with a rich product portfolio including Inhalation Anesthetics (Sevoflurane, Isoflurane, Halothane) and Intrathecal Baclofen therapy for spasticity management.

This role will proactively drive the Quality culture at the site and promote cGMP activities. The QA Validation Engineer will own the site validation program compliance, including change management, qualifying/validating new processes, equipment, and systems, and ensuring alignment with company strategic goals. The position may also serve as a liaison between Operations (manufacturing, packaging, engineering, maintenance) and the QA/QC department for day-to-day activities, capital projects, process improvements, and related initiatives.

Responsibilities

• Arrange, plan, manage, and execute installations, operations, and performance qualifications of packaging, laboratory, and utility systems.
• Schedule, plan, manage, and execute studies for cleaning validations, process validation studies, and author related plans, summary reports, and protocols.
• Review and approve validation project documentation.
• Coordinate and interface with process unit heads, quality, and engineering groups to ensure successful project execution.
• Lead and coordinate cross-functional teams for project validation.
• Prioritize, manage, and execute multiple projects using project management methodologies.
• Oversee external validation resources.
• Support the development of best and proven validation practices based on current industry guidelines.
• Author relevant standard operating procedures to ensure compliance with company policies.
• Support regulatory submissions and agency inspections as requested.
• Champion continuous improvements in the validation department.

Requirements

• Bachelor’s degree or higher in a relevant scientific/technical field.
• 4 or more years of combined experience within the pharmaceutical industry or Regulatory/Compliance, including project management experience preferred.
• Experience in project management.
• Well-organized with a keen attention to detail.
• Knowledge of state and federal pharmaceutical validation laws and regulations.

Skills

• cGMP and Regulatory Compliance: Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretations, lead investigations, and implement decisions.
• Professional Communication: Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
• Computer Literacy: Proficient in Microsoft Outlook, Excel, Word, and other web-based systems.
• Collaboration: Ability to utilize teamwork and problem-solving skills across departments.
• Project Management: Ability to lead projects, identify issues, initiate corrective actions, and complete tasks in a timely manner.

Physical Demands

• Standing/Walking/Sitting: Frequently
• Balancing/Kneeling: Occasionally
• Reaching/Working Overhead: Occasionally
• Keyboard Use/Repetitive Hand Motion: Frequently
• Climbing/Bending: Occasionally
• Pushing/Pulling (up to 25 pounds): Occasionally
• Lifting/Carrying (up to 25 pounds): Occasionally

Working Environment

The role involves moderately undesirable working conditions, including occasional exposure to significant levels of temperature, air pollution, noise pollution, chemical gases, and substances. There is a possibility of minor physical trauma such as cuts, bruises, and minor burns.