Principal Engineer

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

The Principal Engineer is responsible for managing the change control process. This role ensures that all changes to processes, systems, equipment, materials, and documents comply with regulatory requirements and company policies. The individual will oversee the entire lifecycle of change requests, from initiation to implementation, to maintain product quality, compliance, and operational efficiency.

KEY RESPONSIBILITIES: 

• Develop, implement, and maintain the change control process in compliance with FDA, EU GMP, and other regulatory guidelines.
• Manage change control records within the electronic quality management system (RemarQue) and ensure timely review and closure.
• Collaborate with CMOs and cross-functional teams to assess change impact and risk.
• Ensure all change control documentation, including justifications, risk assessments, validation requirements, and implementation plans, are completed accurately.
• Conduct impact assessments to evaluate potential effects of changes on product quality, regulatory compliance, and business continuity.
• Facilitate Change Control Review Board (CRB) meetings, ensuring thorough review, risk assessment, impact assessment and approval of proposed changes.
• Provide support in reviewing and approving CAPA (Corrective and Preventive Actions), product quality complaints.
• Support and lead Escalated Events, Technical Review Meetings, FARs, and market actions (Recalls and market withdrawals).
• Responsible for data collection for quality metrics, scorecards, and quality review board meetings.
• Lead internal audits, support regulatory inspections, address audit findings, and implement corrective measures.
• Identify quality improvement opportunities for efficiency and cost reduction. Supports QMS implementation and Quality Systems harmonization efforts as needed.
• Effective and Efficient communication with internal and external parties.
• Provide training and guidance to employees on change control procedures, regulatory requirements and best practices.
• Lead and mentor the team and improve quality culture and teamwork.
• Support other Departmental activities as assigned by Management.

QUALIFICATIONS:

• Bachelor’s or master’s degree in Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or a related field.
• 8+ years of experience in Quality Assurance / Quality Systems/Change Control management within the Pharmaceutical or Biopharma industry.
• Strong knowledge of FDA regulations (i.e., 21 CFR Part 210, 211, 11, and 820) and ICH guidelines.
• Experience in managing regulatory inspections is highly preferred. 
• Experience managing change controls related to product lifecycle management, process validation, equipment qualification, and facility modifications.
• Excellent problem-solving and analytical skills, including experience with root cause analysis techniques (e.g., Fishbone, FMEA, 5 Whys).
• Effective communication skills, both written and verbal, with the ability to interact with cross-functional teams and regulatory authorities.
• Excellent project management, organizational, communication, and problem-solving skills.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

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We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, disability, military and/or veteran status, or any other Federal or State legally protected classes. 

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com  or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.  

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