Validation Specialist – I (Assistant – 33447) – Las Piedras, PR

• Bachelor’s Degree in Pharmaceutical Science, Natural Sciences, Engineering, or related science.
• Minimum 3 years of experience in a pharmaceutical industry role with hands on experience in technical operations and/or process support role.
• Working knowledge with cGMPs and regulatory requirements as they apply to the pharmaceutical industry is a must.
• Technical knowledge proficiency in manufacturing process to actively participate in problem solving and continuous improvement initiatives directly related to production areas.
• Technical writing experiences related to complex investigations of manufacturing process and protocols. Experience in deviation management, troubleshooting and resolving manufacturing trends.
• Experienced with formal problem-solving techniques, such as root cause analysis, FMEA, CAPA establishment and Lean/Six Sigma tools is required.
• Strong interpersonal and communication skills.
• Fully Bilingual (English and Spanish).
• Computer Skills (Microsoft Office & Project).

• Contributes intermediate to advance level of pharmaceutical support skills under scientific and administrative direction.
• Apply sound scientific methods and analysis while communicating and collaborating across levels. Responsible for providing technical support such as manufacturing support, regulatory documentation and continued process verification.
• Responsible for providing the necessary technical support to assure timely manufacturing of pharmaceutical products in compliance with cGMP’s, safety and environmental regulations, and Merck standards and policies.
• Provides ideas and works on implementation of other continuous improvement, lean and compliance initiatives.

Use tools and systems to achieve product/process robustness and compliance excellence.

1. Leads process problem solving and ensures that root causes, corrective and preventive actions are identified and implemented to prevent recurrence. Documents the problem solving and product technical assessments for deviations within the target closure time. Evaluates deviation trends and recommends actions to achieve continuous improvement and meet site goals.
2. Responsible for monitoring and investigating environmental incidents such as spill and malfunctions to conduct problem solving, identify root cause and implement preventive actions. Prepare technical documents to address regulatory compliance issues and to answer internal/external audits as requested.
3. Responsible for Continuous Process Verification activities within the IPT for in line products (i.e. Risk Assessments, Process Specific Trainings). Proactive Process Analysis owner in the IPT.
4. Responsible for the identification and implementation of scientific and technological opportunities in manufacturing for major quality, cost, cycle time improvements. Analyze data, recommend, and design and implement process performance improvements.
5. Evaluate and solve equipment malfunction.
6. Execute change requests and qualifications for existing equipment. Provide support to PTO in validations for new and existing processes for the IPT.
7. Assists in development of technical training and revision of batch records and SOP’s linked to process robustness experiences.
8. Foster and encourage adherence to Merck Production System (MPS) metrics, design standards and performance utilizing lean tools.
9. Responsible of providing technical support required from operations for quality systems management linked to manufacturing operations.