Process Validation Engineer

Arrowhead Pharmaceuticals, Inc; Verona (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a skilled Process Validation Engineer to join their dynamic team. This role is crucial for ensuring compliance with GMP standards while overseeing the drafting and review of validation documentation. The ideal candidate will bring extensive experience in GMP validation and manufacturing, contributing to the development of groundbreaking therapies. With a commitment to excellence and collaboration, this position offers the chance to make a significant impact in the field of biopharmaceuticals. Join a forward-thinking organization dedicated to advancing healthcare solutions and improving patient outcomes.

Benefits

Competitive salaries

Excellent benefits

Training and mentorship opportunities

Qualifications

• 8+ years of experience in GMP validation or related fields.
• Experience drafting and reviewing validation protocols and reports.
• Deep understanding of GMP regulations and validation principles.

Responsibilities

• Draft and review validation protocols ensuring GMP compliance.
• Manage manufacturing validation activities to meet quality standards.
• Collaborate with teams to align validation strategies with production.

Skills

GMP validation

Technical writing

Communication skills

Problem-solving

Attention to detail

Education

BS/BA in chemistry

BS/BA in biology

BS/BA in biochemistry

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical-stage biopharmaceutical company focused on developing medicines for intractable diseases by silencing disease-causing genes. Using a broad portfolio of RNA chemistries and delivery methods, Arrowhead's therapies leverage RNA interference (RNAi) to achieve rapid, deep, and durable gene knockdown. RNAi is a natural cellular mechanism that inhibits specific gene expression, affecting protein production. Arrowhead's therapeutics aim to address conditions across various therapeutic areas, including those not accessible by small molecules or biologics. The company is headquartered in Pasadena, CA, with R&D teams in Madison, WI, and San Diego, CA, composed of innovative, science-driven employees committed to bringing new therapies to patients.

The Position

We are seeking a highly skilled and motivated Process Validation Engineer with a strong GMP background to join our team. This individual will be responsible for drafting, reviewing, and overseeing process and cleaning validation documentation. The ideal candidate will have at least 8 years of experience in GMP validation or related fields, with a preference for 3+ years of GMP manufacturing experience.

Responsibilities

• Draft and review process validation and cleaning validation protocols and reports, ensuring GMP compliance.
• Manage the execution of manufacturing validation activities, meeting timelines and quality standards.
• Collaborate with cross-functional teams to align validation strategies with production and regulatory requirements.
• Provide technical support during validation and qualification activities.
• Identify risks, propose corrective actions, and improve validation processes.
• Ensure compliance with FDA, EMA, ICH, and other regulatory standards.
• Review and approve validation data and documentation for accuracy and compliance.
• Participate in audits and inspections, providing validation documentation and responses.
• Train and mentor employees on validation processes and GMP standards.

Requirements:

• BS/BA in chemistry, biology, biochemistry, or related scientific field.
• Minimum 5 years of GMP validation or related experience.
• At least 3 years of GMP manufacturing experience preferred.
• Strong communication skills for effective interaction with teams, management, and regulators.
• Excellent technical writing and attention to detail.
• Proficiency in Microsoft Word and Excel.
• Experience drafting and reviewing validation protocols and reports.
• Deep understanding of GMP regulations, validation principles, and industry best practices.
• Knowledge of process and cleaning validation activities, including testing, execution, and data analysis.
• Problem-solving skills and meticulous attention to detail.
• Experience with regulatory submissions and inspections in pharmaceutical or biopharmaceutical manufacturing.

Preferred:

• Six Sigma or Lean certifications.

Salary range: $90,000 — $120,000 USD

Arrowhead offers competitive salaries and excellent benefits.

Applicants must have authorization to work in the US.