Process Validation Specialist

hace 2 meses

Manatí, Puerto Rico RCM Technologies, Inc. A tiempo completo
Job Title: Sr. Scientist, Product Transfer Support
Job Function: The selected candidate will support the Pharmaceutical Manufacturing Process Validation protocols development, execution, and reporting.
Length of Assignment: months + full time
Location: Manati, PR (On-site)

Scope of Job
  • RCM is seeking an experienced Process Validation Contributor for our leading contract drug manufacturing client.
Primary Responsibilities
  • Provides technical validation support, within a product transfer exercise, of process upgrades, replacements, and modifications in the manufacturing/production area.
  • Develops and executes validation protocols and reporting.
  • Applies advanced and diverse validation principles to the design and implementation of process modifications.
  • Develops, organizes, analyzes, and presents interpretation of results for operational issues and validation projects of significant scope and complexity.
  • Completes complex assignments requiring development of new and/or improved validation engineering techniques and procedures.
  • Applies knowledge of validation 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.
Qualifications
  • Thorough knowledge of GMP regulations and guidelines.
  • Thorough knowledge of process validation within the FDA regulated industry. Knowledge of equipment cleaning process validation is plus.
  • 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.
Education & Certifications
  • Bachelor's degree (Engineering, Science) and years of directly related experience within the life sciences industry.

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