Biopharma Process Validation Engineer – PPQ Readiness

Valspec; Non (OK); On-site; USD 60,000 - 110,000; Full time

Benefits offered by this job

Premium medical coverage

401(k) with company match

Tuition reimbursement

Unique performance incentives

Job summary

Valspec is seeking an experienced Process Engineer to support process validation and PPQ readiness at a biopharmaceutical manufacturing facility in Sanford, NC. The role focuses on validation strategy, protocol authorship, qualification planning, and cross-functional execution to ensure PPQ implementation and GMP compliance.

The candidate will collaborate with Manufacturing, Quality, Engineering, and Validation teams to drive qualification activities, manage studies, and support issue resolution

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• Experience supporting process validation and PPQ readiness in pharma manufacturing.
• Strong technical writing for protocols and reports.
• Experience coordinating qualification studies and validation execution.
• Knowledge of GMP, process validation concepts, and FMEA risk assessment.
• Excellent organizational, communication, and cross-functional collaboration skills.

Responsibilities

• Assess current process validation activities and identify remediation gaps.
• Develop validation strategies, action plans, and roadmaps.
• Author validation protocols and GMP reports.
• Develop qualification strategies for solution mixing, hold studies, and related qualifications.
• Coordinate and track execution of qualification and validation activities.
• Review FMEA outputs and align CQAs and CPPs.
• Collaborate with Manufacturing, Quality, Engineering, and SMEs for successful execution.
• Participate in project meetings and support readiness efforts.

Skills

Process validation

PPQ readiness

Technical writing

Cross-functional collaboration

GMP compliance

Risk assessment (FMEA)

Project coordination

Education

Bachelor's degree in Engineering

Job description

Valspec is seeking an experienced Process Engineer to support process validation and PPQ readiness at a biopharmaceutical manufacturing facility in Sanford, NC. The role focuses on validation strategy, protocol authorship, qualification planning, and cross-functional execution to ensure PPQ implementation and GMP compliance.

The candidate will collaborate with Manufacturing, Quality, Engineering, and Validation teams to drive qualification activities, manage studies, and support issue resolution