Senior Manufacturing Engineering Lead, Validation & Operations

TalentAlly; North Carolina; On-site; USD 147,000 - 203,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Paid Vacation

Job summary

Biogen is seeking an experienced Manufacturing Engineering Lead in the United States to oversee the installation, validation, reliability and optimization of manufacturing process equipment and cGxP warehouse technologies. You will guide a team of engineers, partner with Quality, EHS and cross-functional groups, and drive continuous improvement in a regulated biopharmaceutical environment.

The role requires deep technical knowledge in biopharmaceutical manufacturing, validation, and equipment

Qualifications

• Bachelor's degree in engineering; 10+ years in biotech/pharma or adjacent industry.
• Experience leading engineering professionals, contractors, or cross-functional teams for 2+ years.
• Deep GMP validation and manufacturing/Facilities knowledge; familiarity with biopharma operations.
• Experience with FDA or regulatory investigations and corrective actions; GMP validation leadership.

Responsibilities

• Lead and develop the Manufacturing Engineering function with a team of 7–15 employees.
• Ensure reliability, safety, compliance of manufacturing equipment and systems.
• Set departmental goals, metrics, and operating priorities aligned with site objectives.
• Represent Site Engineering & Facilities in leadership discussions on strategy and risks.
• Lead validation strategy, execution, and lifecycle management per QMS and global procedures.
• Present and defend programs during regulatory audits and inspections.
• Manage budgets, resources, and capital portfolio; drive continuous improvement.
• Provide technical direction during critical equipment issues to sustain operations.

Skills

Engineering degree

10+ years biotech/pharma

2+ years leadership

GMP validation

GxP knowledge

FDA regulatory interaction

Budget & project management

Cross-site initiatives

Education

Bachelors in Engineering

Tools

DCS

PLC

P&IDs

SOPs

Job description

Biogen is seeking an experienced Manufacturing Engineering Lead in the United States to oversee the installation, validation, reliability and optimization of manufacturing process equipment and cGxP warehouse technologies. You will guide a team of engineers, partner with Quality, EHS and cross-functional groups, and drive continuous improvement in a regulated biopharmaceutical environment.

The role requires deep technical knowledge in biopharmaceutical manufacturing, validation, and equipment