Validation Specialist

RCM Technologies

Barceloneta, PR
Permanente
Tiempo completo

Hace 26 días

Job Title: Validation Specialist
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.

Primary Responsibilities

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.

Qualifications

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.

Education & Certifications

Bachelor's degree (Engineering, Science) and 5 years of directly related experience within the life sciences industry.

Equal Opportunity StatementRCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.DisclaimerThis job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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