Job Title: Sr, Scientist, Product Transfer Support
Job Function: The Sr. Scientist will support the Pharmaceutical Solid Dose Manufacturing Process Validation protocols development execution and reporting.
Length of Assignment: 6 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 of solid dose drug products.
• 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 5 years of directly related experience within the life sciences industry.

About RCM:
RCM Life Sciences 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.
Equal Opportunity Statement
RCM 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.
Disclaimer
This 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.