Core Hours: Monday - Friday, 8:00 am - 5:00 pm
Purpose and Scope
The Senior Automation CSV Engineer will lead the design, implementation, and validation of automated systems and new technology solutions within a sterile injectable pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and company standards for computerized systems, automation platforms, and AI-enabled technologies used in production, quality control, and data analytics.
Essential Duties & Responsibilities
- Automation and Computer System Validation:
- Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5, 21 CFR Part 11, FDA’s CSA for Production and Quality System Software, Annex 11, Annex 22, and PIC/S.
- Perform risk assessments and ensure data integrity
- Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports).
- System Lifecycle Management:
- Oversee system implementation, upgrades, and change control for automation and computer systems.
- Collaborate with IT, Engineering, and Quality teams to maintain validated state of systems.
- Regulatory Compliance:
- Ensure adherence to cGMP, FDA, EMA, and global regulatory guidelines for sterile injectable manufacturing.
- Support audits and inspections by providing validation evidence and technical expertise.
- Innovation & Continuous Improvement:
- Identify opportunities to integrate new technologies and advanced analytics for process optimization and predictive maintenance.
- Drive digital transformation initiatives.
- Quality Oversight & Approval:
- Provide independent quality oversight for automation and computer system validation activities.
- Review and approve validation protocols, reports, and change control documentation to ensure compliance and data integrity.
- Act as a quality representative during system implementation and qualification phases.
- Adhere to company and departmental timelines with high accuracy and quality.
- Maintain an atmosphere of teamwork, cordiality, and respect towards co-workers.
- Performs other duties as assigned.
Core Values
This 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
- Excellent organizational and project management skills.
- Excellent oral and written communication skills.
- Ability to work independently with minimal supervision and as part of a cross-functional team.
- Advanced knowledge of Automation and CSV/CSA principles, industry guidance, regulatory requirements, cGMP practices, and ICH guidelines.
- Strong project management and cross-functional leadership skills.
- Ability to author strong technical reports free of errors.
- Advanced knowledge with Microsoft Office Suite, and various GMPS systems such as Veeva eQMS, Maximo CMMS, BMS, LIMS, CDS, and ERPs.
- Familiarity with SCADA, PLC, MES, and AI platforms from simple context analysis tools to large language modeling, prompt engineering and the role of human interaction for process engineering and establishment of trustworthy data.
- Advanced troubleshooting and problem-solving skills.
- Ability to manage multiple projects concurrently and under tight time constraints.
Education & Experience
- Bachelor’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field required
- Master’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field preferred
- Minimum of 8 years’ experience in pharmaceutical automation and computerized system validation.
- Strong knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in GAMP 5, 21 CFR Part 11, Annex 11 and knowledge of Annex 22 compliance.
- Proficiency in risk-based validation and data integrity principles.
Working Conditions
- Working conditions include general office environment.
- Business demands may require working extended hours.
Compensation and Benefits
- Pay: $138,000 to $148,000 per year depending on experience
- Bonus Eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits (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.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
