Position Available: Senior Validation Engineer (Automation)
Role Overview: We are looking for a talented Senior Validation Engineer to ensure cleaning processes meet regulatory standards and company policies. This critical role involves developing, executing, validating, and monitoring cleaning procedures to maintain product quality, safety, and compliance.
Key Responsibilities:
- Develop, revise, and implement comprehensive commissioning, qualification, and validation documentation for equipment, systems, software, and processes.
- Conduct thorough tests, document results meticulously, and ensure all activities align with project timelines and regulatory requirements.
- Provide expert recommendations for design or process changes based on test results during validation execution.
- Maintain precise and comprehensive qualification and validation records to ensure traceability and compliance.
- Develop, review, and execute robust testing protocols for cleaning validation.
- Offer actionable suggestions for design or process improvements based on thorough test outcomes.
- Possess deep knowledge of capital equipment implementation and process operations within manufacturing environments.
- Conduct risk-based assessments of cleaning processes to ensure compliance and minimize contamination risks.
- Investigate cleaning failures or deviations, perform root cause analysis, and implement corrective and preventive actions (CAPA).
- Collaborate effectively with operations, quality assurance, and R&D teams to optimize and validate cleaning processes.
Qualifications:
Basic Qualifications:
- Bachelor of Science in a relevant technical field (e.g., engineering, life sciences, or equivalent) from an accredited institution.
- Minimum of 5 years of relevant industry experience in a similar role.
Preferred Qualifications:
- Experience with validation documentation, including User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Familiarity with selecting and validating cleaning agents, methods (CIP/SIP or manual cleaning), and residue testing techniques (e.g., HPLC, TOC, conductivity).
- Expertise in conducting risk-based assessments of cleaning processes to ensure compliance and minimize contamination risks.
- Experience investigating cleaning failures or deviations, performing root cause analysis, and implementing corrective and preventive actions (CAPA).
- Knowledge of change control processes related to updates in cleaning procedures.
- Extensive experience with cleaning validation for various types of manufacturing equipment, such as bioreactors, filtration systems, filling lines, and other process equipment used in pharmaceutical or biotech production.
- Proficiency in residue analysis techniques, including swab and rinse sampling, TOC, and UV/Vis spectroscopy.
- Proven ability to collaborate effectively with operations, quality assurance, and R&D teams to optimize and validate cleaning processes.
Benefits:
- Career Advancement: Dynamic, fast-growing company with ample opportunities for professional growth and career advancement.
- Competitive Salary: Performance-driven incentive programs to reward your contributions.
- Comprehensive Insurance: Company-paid Life, Short-Term, and Long-Term Disability Insurance for peace of mind.
- Medical, Dental, and Vision: Comprehensive plans to cover your health needs.
- Flexible Spending Options: Including FSA, DCARE, and Commuter Benefits to suit your lifestyle.
- Health Savings Account (HSA): Options for tax-advantaged savings.
- 401(k) Retirement Plan: Employer matching contributions to help you save for the future.
- Generous Paid Time Off: With rollover options and paid holidays to support work-life balance.
- Additional Benefits: Access to Supplemental Life, Hospital, Critical Illness, and Legal Insurance.
