Validation Associate, Oral Solid Dosage Manufacturing

The Validation Associate supports qualification and validation activities for facilities, utilities, equipment, and manufacturing processes within a cGMP-regulated oral solid dosage pharmaceutical environment. This role is responsible for authoring, executing, coordinating, and maintaining validation documentation and related quality system records to ensure systems and processes remain compliant, effective, and inspection-ready. The Validation Engineer partners closely with Manufacturing, Packaging, Quality Assurance, and other cross-functional teams to support validation lifecycle activities, change implementation, and continued operational compliance. This position supports manufacturing, equipment, process, and cleaning validation activities within an oral solid dosage pharmaceutical environment and is not a computer systems validation (CSV) role.

Key Responsibilities:

• Author, execute, and maintain IQ, OQ, PQ, and requalification protocols and reports for GMP equipment, systems, utilities, and processes.
• Support commissioning, qualification, and startup activities for new or modified equipment and systems used in oral solid dosage manufacturing and packaging operations.
• Review changes for validation impact and support associated documentation, including change controls, deviations, CAPAs, and SOP revisions.
• Compile, analyze, and summarize validation study data to prepare accurate, complete, and GMP-compliant reports.
• Troubleshoot validation-related issues, assess atypical conditions encountered during execution, and coordinate resolution with user departments and Quality Assurance.
• Support the ongoing maintenance and improvement of site validation programs, templates, and procedures to ensure continued regulatory compliance and operational readiness.

What We’re Looking For

Experience:

• 3–5 years of experience in validation, qualification, engineering, or a related technical function within a cGMP-regulated pharmaceutical manufacturing environment.
• Direct hands-on experience authoring and/or executing IQ, OQ, and PQ protocols and reports for GMP equipment, systems, or processes required.
• Experience supporting equipment, process, and/or cleaning validation in oral solid dosage pharmaceutical manufacturing strongly preferred .

Education:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or another relevant technical discipline required.

Skills & Knowledge:

• Working knowledge of cGMPs, GDP, data integrity principles, and regulatory expectations related to pharmaceutical validation activities.
• Strong understanding of validation lifecycle activities, including IQ/OQ/PQ, requalification, and change impact assessment.
• Strong technical writing, analytical, and problem-solving skills.
• Ability to manage multiple projects and priorities in a deadline-driven GMP environment.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Experience with statistical or data analysis tools such as Minitab or JMP preferred.
• Strong communication skills and ability to work effectively across cross-functional teams.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)