Validation Engineer

SCA Pharma; Poquonock (CT); On-site; USD 110,000 - 150,000; Full time

Job summary

SCA Pharmaceuticals is a dynamic rapidly growing company dedicated to providing high quality medications critical to saving and sustaining human life. The Validation Engineer will oversee aseptic process simulations (media fills), equipment qualification/requalification, and facility/utility qualification, supporting Operations and Quality with a compliant validation schedule.

This role requires a Bachelor's in life sciences or engineering, 5+ years of validation experience in pharma, strong

Qualifications

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 5+ years of direct validation experience in pharmaceutical/life sciences.

Responsibilities

• Execute validation and qualification activities (equipment, media fills, facility, utility, environmental monitoring system) including protocol prep, scheduling, execution, and final reports.
• Ensure C&Q and validation project deliverables comply with current regulations and SOPs.
• Maintain revalidation/requalification lifecycle per SOPs.
• Execute airflow patterns (smoke studies) of compounding operations.
• Manage schedule for outsourcing HEPA filter recertification and approve activities.
• Coordinate validation activities with functional groups to maintain schedule compliance.
• Develop/improve validation programs to align with cGMPs and industry standards.
• Represent validation in teams for procurement, installation, troubleshooting, and process improvement.
• Conduct deviation investigations to identify root causes and drive CAPA actions.
• Generate and approve SCA Certificate of Compliance.

Skills

MS Word

Excel

PowerPoint

Communication skills

Technical writing

Critical thinking

cGMP knowledge

Aseptic processing knowledge

Education

Bachelor’s degree in life sciences, engineering, or related discipline

Job description

Description

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.

Summary:

The Validation Engineer oversees the aseptic process simulations (media fills), equipment qualification and requalification, facility and utility qualification and requalification. This position supports Operations and Quality and will maintain a compliant schedule of validation activities and will serve as a technical resource in process improvement initiatives that require a validation expertise.

Essential functions:

• Execute validation and qualification activities (equipment, media fills, facility, utility, environmental monitoring system) to include protocol preparation, scheduling execution, protocol execution, and final report preparation.
• Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports; Risk Assessment; Traceability Matrix, etc.) are compliant with the current regulations, current industry practices, and internal policies and procedures.
• Maintain a revalidation / requalification lifecycle and executes accordingly per Standard Operating Procedures (SOPs).
• Execute airflow patterns (smoke studies) of compounding operations.
• Manage a schedule for outsourcing HEPA Filter recertification. Oversee and approve the outsourced activities.
• Effectively coordinate and communicate all due validation/qualification activities with relevant functional groups to enable compliance to the validation / qualification schedule.
• Develops/improves validation and qualification programs as needed to remain current with cGMP’s and industry standards.
• Represent validation in teams assembled to procure, install, troubleshoot systems, equipment, and processes.
• Conduct and/or participate in deviation investigations as appropriate to identify root causes and define corrective and/or preventative actions (CAPA).
• Drive CAPA’s assigned to the validation department
• Generate and approve SCA Certificate of Compliance

Requirements

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 5+ years of direct validation experience in pharmaceutical and/or life sciences.

Desired Knowledge, Skills, and Abilities:

• Proficient in MS Word, Excel, and PowerPoint
• Have effective communication (both written and verbal).
• Demonstrated strong technical writing skills, decision making abilities and critical thinking.
• Demonstrated knowledge and understanding of cGMP’s, industry guidance associated with aseptic processing, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
• Knowledge and experience in leading aseptic process simulations (media fills)

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.