Validation Specialist
RCM Technologies
- Barceloneta, PR
- Permanente
- Tiempo completo
Job Function: Process/Equipment Validation Support
Job Type: Full Time Contract
Location: Barceloneta, PR (On-site)About RCM:RCM Life Sciences & IT is a leading provider of Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America and PR.Scope of Job
- RCM is seeking an experienced Process/Equipment Validation Contributor for our leading manufacturer of animal drug products client.
- Provides technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the manufacturing/production area. Preferably in the packaging area.
- Develops and executes validation protocols and reporting.
- Applies advanced and diverse validation engineering principles to the design and implementation of major systems or process modifications and/or capital projects.
- Develops, organizes, analyzes, and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
- Completes complex or Client assignments requiring development of new and/or improved validation engineering techniques and procedures.
- Employs advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
- Applies knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
- Develops technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Works with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex processes, system/facility modifications.
- Works with project managers to complete the validation responsibilities of engineering projects within schedule, budget, and quality constraints.
- Thorough knowledge of GMP regulations and guidelines.
- Thorough knowledge of process validation and equipment qualification. Packaging process validation is a must.
- Excellent communication skills, both verbal and written.
- Knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance.
- Experience with risk analysis and risk management practices and tools.
- The ability to work both independently and with teams at various levels in the organization.
- Excellent organizational skills and attention to detail and accuracy.
- Bachelor's degree (Engineering, Science) and 5 years of directly related experience within the life sciences industry.