Engineer Pharma Validation

Job Summary

Responsibilities

• Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic manufacturing.
• Perform engineering studies to determine if projects are feasible.
• Develop, prepare and install equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices.
• Develop and execute cleaning validations.
• Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols.
• Develop timelines for all projects and ensure that deadlines and goals are being met.
• Frequently update management and team on progress.
• Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion.
• Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements.
• Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems.

Qualifications

• Bachelor of Science Degree in Biology, Chemistry or Engineering.
• At least 2 year of validation experience in a cGMP Device or Drug environment.
• Experience with validations of USP water, controlled environments or equipment validations in a regulated environment.
• Experience with validation documentation and related change control.
• Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner.

Preferred Qualifications

• Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.
• Six Sigma certification.
• 3 years of validation experience in a cGMP Device or Drug environment.
• Validation experience in a pharmaceutical or Medical Device manufacturing environment.
• Experience with validation of various product types such as liquid products, solid dosage products, and multi-component products.

Pay

The Anticipated Salary Range For This Position is $73,000.00 - $110,000.00 Annual. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.

Benefits

• Health insurance
• Life and disability
• 401(k) contributions
• Paid time off