Sr. Validation Scientist 3080189
Job Title: Senior Validation Scientist 3080189
Location: East of Puerto Rico (Hybrid/Preferred Onsite)
Shift:Administrative Shift
Positions Available: 1
Duration: Approximately 5 Months
Job Summary
Our client is seeking a highly skilled Senior Validation Scientist to provide technical validation engineering support for process and equipment upgrades, replacements, and modifications within laboratory, manufacturing, and manufacturing support environments. This role requires independent problem-solving abilities and expertise in process validation, making a direct impact on operational excellence and regulatory compliance.
The selected candidate will apply advanced validation engineering principles, ensuring efficiency and reliability in process operations while adhering to regulatory and compliance requirements.
Key Responsibilities
- Troubleshoot and resolve complex validation issues with minimal supervision.
- Apply advanced and diverse validation engineering principles to major system or process modifications.
- Analyze and interpret results for operational challenges and validation engineering projects of significant scope.
- Develop and refine validation engineering techniques, policies, and procedures that impact multiple organizational units.
- Lead and oversee validation engineering tasks, including supervision of small teams of engineers or technicians.
- Develop technical solutions to complex challenges requiring innovation and creativity.
- Collaborate with cross-functional teams, including manufacturing, process development, utilities, facilities, laboratories, and quality assurance.
- Ensure timely and cost-effective completion of validation-related responsibilities in engineering projects.
- Manage project budgets and resource allocation to align with organizational goals.
- Participate in regulatory inspections and support compliance efforts.
Preferred Qualifications
- Educational Background:
- Doctorate in Engineering or a Scientific Field (Biology, Microbiology, Biotechnology, Chemistry, etc.), OR
- Master’s Degree with 3+ years of directly related experience, OR
- Bachelor’s Degree with 5+ years of directly related experience, OR
- Associate’s Degree with 10+ years of directly related experience, OR
- High School Diploma / GED with 12+ years of directly related experience.
- Industry Experience:
- Experience in a regulated environment such as Biotechnology, Pharmaceuticals, or Medical Devices.
- Strong background in Validation Engineering, with a preference for Process Validation.
- Hands-on experience with equipment qualification, cleaning validation, and sterilization.
Core Competencies & Skills
- Advanced expertise in validation processes, including equipment qualification and process validation.
- Strong analytical and problem-solving skills to address a variety of technical challenges.
- Ability to work independently and exercise sound judgment in technical decision-making.
- Experience in regulatory compliance and familiarity with FDA regulations or equivalent industry standards.
- Excellent leadership and team collaboration skills, with the ability to guide peers and supervise project teams.
- Effective communication skills for cross-functional collaboration and stakeholder engagement.
- Ability to manage multiple projects simultaneously while ensuring compliance with schedules and budgets.
- Proficiency in financial analysis tools, project cost development, and vendor/contractor management.
- Strong decision-making abilities, conflict resolution skills, and negotiation expertise.
Additional Considerations
Due to the nature of this role, non-standard work shifts may be required, including second/third shifts, weekends, and holidays. Candidates should demonstrate flexibility and a proactive approach to meeting project demands and deadlines.
Why Join Our Client’s Team?
This opportunity offers a dynamic and challenging environment where you will contribute to high-impact validation initiatives while enhancing your expertise in a regulated industry. Be part of a team that drives innovation and excellence in manufacturing operations.
Interested candidates should apply by submitting an updated resume through the job description link. We look forward to reviewing your application!