Validation Engineering Lead – Biotech Ops

Ferring Holding SA; Roseville (MN); On-site; USD 107,000 - 120,000; Full time

Job summary

Ferring is seeking an Engineering Supervisor for Validation Engineering in Roseville, MN. The role provides direction to the Validation Engineering group, ensuring equipment lifecycle management aligns with regulatory and site requirements.

Responsibilities include leading validation activities, supporting Computer System Validation, and collaborating with QA, vendors, and end users to implement improvements in a regulated biopharmaceutical setting.

Qualifications

• College degree (life sciences degree preferred) or equivalent experience.
• Minimum 5 years of experience providing oversight for Validation projects.
• 2+ years Supervisory or Lead experience.
• 5+ years experience in Biotech/Pharmaceutical Industry or similar, regulated industry required.
• Excellent analytical, interpersonal and communication skills, including written and verbal communication.
• Investigation and CAPA experience preferred.
• Previous experience as validation engineer for a life sciences company regulated by the FDA required.
• Familiarity with cGMP, 21 CFR 210/211, 21 CFR part 11, Annex 11, GAMP 5 and Data Integrity concepts.

Responsibilities

• Partner with Quality Assurance teams, external vendors, and end users to improve validation practices.
• Lead system implementations, problem resolution, and process improvement projects.
• Perform gap analysis of validation documentation, systems, and practices; recommend corrective actions.
• Conduct periodic system reviews with business and system owners.
• Report key metrics and help update related policies and procedures.
• Support during regulatory inspections.

Skills

Leadership

Verbal & written communication

Attention to detail

Drive for results

Negotiation & influence

Education

College degree (life sciences preferred)

Tools

Microsoft Word

Excel

PowerPoint

Access

Adobe Acrobat

Job description

Ferring is seeking an Engineering Supervisor for Validation Engineering in Roseville, MN. The role provides direction to the Validation Engineering group, ensuring equipment lifecycle management aligns with regulatory and site requirements.

Responsibilities include leading validation activities, supporting Computer System Validation, and collaborating with QA, vendors, and end users to implement improvements in a regulated biopharmaceutical setting.