Core HoursMonday - Friday, 8:00 am - 5:00 pm
Purpose and ScopeThe Senior Quality Validation Engineer is responsible for driving validation initiatives and execution across multiple systems and processes in a sterile injectable manufacturing environment. This role ensures compliance with cGMP, FDA, EU, and other regulatory requirements and provides technical expertise, guidance and mentorship to junior engineers and peers, supporting their professional development without direct supervisory responsibility.
Essential Duties & Responsibilities- Plan and coordinate validation activities for cross-functional projects, including but not limited to validation plans, protocols, and reports
- Oversee and approve validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes.
- Support cleaning validation and process validation activities.
- Oversee validation documentation to ensure accuracy, completeness, and regulatory compliance and expectations.
Lead risk assessments, develop risk management tools (e.g., FMEA, HACCP) and support change control evaluations.
- Design and implement validation strategies aligned with regulations.
- Analyze validation data, prepare comprehensive reports, and ensure audit readiness.
- Collaborate with QA, Engineering, Manufacturing, Microbiology, and Regulatory Affairs to ensure alignment and timely execution of validation deliverables
- Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
- Provide validation guidance and support to various teams in developing and executing protocols.
- Support investigations and CAPAs related to validation deviations or failures.
- Contribute to continuous improvement initiatives in validation practices.
- Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
- Support internal and external audits and inspections.
- Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
- Perform other related duties as assigned.
Core ValuesThis position is expected to operate within the framework of Tolmar's Core Values:
- Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
- Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
- Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
- Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
- Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
Knowledge, Skills & Abilities- Proficient knowledge in Microsoft Office Suite.
- Expert knowledge of GMP regulations and validation guidelines.
- Proven skills in leading medium to large projects and influencing cross-functional teams.
- Advanced technical writing and documentation skills.
- Excellent oral and written communication skills.
- Strong project management and cross-functional collaboration skills.
- Effective troubleshooting and problem-solving skills.
- Knowledge of science and risk-based approaches aligned with industry best practices
- Ability to maintain gowning requirements as needed to access controlled areas.
- Ability to guide complex validation initiatives and mentor junior staff.
- Ability to work both independently and in conjunction with a team.
- Advanced ability to develop and implement creative solutions to problems.
- Ability to train junior engineers in validation principles and philosophies without direct supervisory responsibilities.
Education & Experience- Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical field.
- Minimum of 8 years' of experience in quality and sterility assurance, with demonstrated experience influencing and guiding teams in sterile pharmaceutical environments.
- Experience with regulatory inspections and audit readiness.
- Experience with aseptic processing, cleanroom classifications, and environmental monitoring.
- Experience with validation software or electronic document management systems.
Working Conditions- Working conditions include general office environment, laboratory and manufacturing settings (clean rooms where gowning is required)
- Business demands may require working extended hours.
Compensation and Benefits- Pay: $138,000 to $148,000 depending on experience
- Bonus eligible
- Benefits summary: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
