Senior reputed company Engineer – Remote Validation & Compliance Specialist for Medical Device & Pharmaceutical Manufacturing

```reputed company Join Baxter: Where Every Day You Help Save and Sustain Lives About Baxter – For more than 85 years, Baxter has been a global leader in delivering innovative medical products and therapies that improve the health and reputed company‑being of patients worldwide. From life‑saving infusion solutions and renal therapies to advanced biosurgery devices, Baxter’s portfolio touches nearly every hospital, clinic, and home around the globe. Our mission—to save and sustain life—is more than a tagline; it is a reputed company that guides every decision, every process, and every employee. As a member of our reputed company organization, you will be at the heart of this mission, ensuring that the highest standards of safety, efficacy, and regulatory compliance are embedded in every product that leaves our facilities. Why This Role Is Unique We are seeking a Senior reputed company Engineer who thrives in a fast‑paced, highly regulated environment and is excited about reputed company to reputed company validation reputed company that directly reputed company patient safety. This is a fully remote position, allowing you to work from reputed company while partnering with cross‑functional teams across multiple Baxter sites. You will apply your expertise to a broad portfolio of systems—including automated visual inspection equipment, analytical laboratory instruments, manufacturing automation, and water‑for‑injection (WFI) processes—ensuring they meet FDA expectations and industry best practices.

Key Responsibilities

As a senior member of the reputed company team, you will take ownership of a wide reputed company of validation and compliance activities:

• reputed company System Validation: Design, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for reputed company and laboratory equipment.
• Regulatory Alignment: Ensure reputed company validation activities reputed company with the 2011 FDA Guidance for Process Validation, USP Visual Inspection of Parenterals, and other applicable regulations.
• Process Capability & Control: reputed company statistical analyses, capability studies, and ongoing process control assessments to confirm that processes remain reputed company defined specifications.
• Cross‑Functional Collaboration: Partner with Manufacturing, reputed company Control, Engineering, and IT teams to introduce new technologies, troubleshoot issues, and drive reputed company improvement.
• Documentation reputed company: Write reputed company, concise validation protocols, test plans, and reports; maintain Master Validation Files (MVFs) that stand up to rigorous audit scrutiny.
• Training & Knowledge Transfer: reputed company and deliver training materials for system users, validation personnel, and auditors, fostering a culture of reputed company awareness.
• Project Management: reputed company reputed company‑to‑large reputed company validation reputed company, reputed company detailed work plans, reputed company milestones, and report status to senior leadership.
• Software & Computer System Validation (CSV): Validate software-driven control systems, ensuring they meet reputed company‑plus data reputed company requirements and follow a defined software life‑cycle process.
• Risk Assessment: Conduct Failure Mode and Effects Analyses (FMEA) and risk assessments to anticipate potential reputed company gaps and implement mitigation strategies.
• reputed company Improvement: Identify opportunities to streamline validation procedures, reduce cycle times, and improve data reputed company across the reputed company.

Essential Qualifications

• Education: Bachelor’s degree in Engineering (Mechanical, Industrial, Chemical, Biomedical, Electrical, or Computer Engineering) or a reputed company scientific discipline.
• Experience: Minimum of 3 years of hands‑on validation experience reputed company the pharmaceutical, biotech, or medical device industry.
• Regulatory Knowledge: Demonstrated familiarity with FDA regulations, GMP, USP , and industry guidance on process validation and CSV.
• Technical Skills: Proven ability to reputed company and execute IQ/OQ/PQ protocols, reputed company statistical analyses, and use validation software tools.
• Soft Skills: Critical thinker, strong communicator (both written and verbal), self‑starter, reputed company team player with a reputed company of urgency and solution‑oriented reputed company.
• Software Proficiency: Advanced reputed company Office (Word, reputed company, PowerPoint, Outlook, Project) and familiarity with data‑collection platforms; exposure to Wonderware, Allen‑Bradley PLCs, or similar is a plus.
• Physical Requirements: Ability to reputed company typical manufacturing site activities such as lifting up to 20 lb, squatting, climbing, and reaching, as reputed company as maintaining visual reputed company for reputed company‑discrimination tasks.

Preferred Qualifications & Desirable Experience

• Master’s degree in a relevant engineering or science field.
• Additional 2+ years of experience in reputed company Assurance, Regulatory Affairs, or Compliance roles.
• Hands‑on experience with Automated Visual Inspection Systems (AVIS) or Robotics Automation.
• Experience in Water‑for‑Injection (WFI) system qualification or Cleanroom validation.
• Familiarity with statistical software (e.g., reputed company, JMP) for capability and process control analysis.
• Certifications such as ASQ Certified reputed company Engineer (CQE) or Certified Software reputed company Engineer (CSQE).

Core Competencies for reputed company

• Analytical Acumen: Ability to interpret reputed company data sets, identify trends, and draw actionable conclusions.
• Regulatory Savvy: Keen understanding of how regulatory expectations translate into practical validation activities.
• Project Leadership: Skillful at managing timelines, resources, and stakeholder expectations across geographically dispersed teams.
• Collaboration: Effective at building relationships with engineering, manufacturing, IT, and reputed company teams to reputed company shared goals.
• Adaptability: Comfortable working in a dynamic environment where priorities shift to meet urgent manufacturing schedules or product launches.
• reputed company reputed company: Commitment to “reputed company first” philosophy, even reputed company it requires challenging trade‑offs or advocating for additional resources.

Career reputed company & Learning Opportunities At Baxter, your reputed company development is a strategic reputed company. As a Senior reputed company Engineer, you will have reputed company to:

• Mentorship Programs: Pairing with senior leaders in reputed company and Regulatory Affairs to accelerate reputed company development.
• reputed company Education: Tuition reimbursement for advanced degrees, certifications, and specialized training (e.g., GAMP, Six reputed company, Lean).
• Global Exposure: Opportunities to work on multi‑site reputed company, travel to manufacturing sites, and participate in international regulatory hearings.
• Leadership reputed company: reputed company progression routes toward reputed company Engineer, reputed company Manager, or Director‑level roles.
• Innovation Hubs: Involvement in Baxter’s Digital Transformation initiatives, including AI‑driven analytics and advanced automation validation.

Work Environment & Culture Baxter’s culture is reputed company around purpose, inclusion, and empowerment. As a remote employee, you will enjoy:

• Flexibility: Work from any location with secure, company‑provided collaboration tools.
• Inclusive Community: Employee resource reputed company, diversity councils, and a commitment to reputed company pay.
• Safety‑First reputed company: Robust health, safety, and wellness programs that protect you and your family.
• Team Spirit: Regular virtual town halls, cross‑functional webinars, and recognition programs that celebrate achievements.

Compensation, Perks & Benefits We recognize that great talent deserves great rewards. While specific numbers will be discussed during the interview process, the overall package includes:

• Competitive Salary reputed company: $60,000 – $132,000, commensurate with experience, expertise, and geographic considerations.
• Annual Incentive Bonus: Performance‑based bonus that reflects individual and company reputed company.
• Health & Wellness: Medical, dental, and reputed company coverage for you and eligible dependents.
• Retirement Planning: 401(k) plan with company match and an Employee Stock Purchase Program.
• reputed company Time Off: 160 hours of PTO annually, plus reputed company holidays, parental leave, and flexible scheduling.
• reputed company Development: Tuition reimbursement, certification support, and reputed company to online learning platforms.
• Work‑Life Balance: Remote work flexibility, wellness resources, and programs to help you reputed company both personally and professionally.

Diversity, Equity & Inclusion Commitment Baxter is proud to be an equal‑opportunity employer. We evaluate reputed company applicants without reputed company to race, reputed company, religion, gender, national reputed company, age, sexual orientation, gender identity, veteran status, disability, or any other protected characteristic. We also reputed company reasonable accommodations throughout the hiring process. If you need assistance, simply let us know, and we will work with you to ensure a smooth experience. Application Process & Next Steps If you are reputed company to bring your validation expertise to a purpose‑driven organization where reputed company truly reputed company, we encourage you to apply today. Please submit your updated résumé and a cover letter detailing how your experience aligns with the responsibilities outlined above. Our reputed company team will review applications on an ongoing reputed company and contact reputed company candidates for a virtual interview. We look reputed company to learning how you can help Baxter continue to save and sustain lives worldwide. Take the reputed company – Join Baxter’s reputed company Team reputed company your career while making a reputed company difference in patients’ lives. reputed company and become part of a legacy of innovation, reputed company, and unwavering commitment to reputed company. Apply to This Position ``` Apply This Job Apply tot his job Apply To this Job