Biopharma Manufacturing Engineering Lead - Validation & Ops

Biogen, Inc.; North Carolina; On-site; USD 147,000 - 203,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Fitness & Wellness programs

Paid vacation and holidays

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen, Inc. seeks an experienced Manufacturing Engineering Lead to guide a 7–15 person team and own the validation, reliability, and optimization of manufacturing process equipment and warehouse technologies.

You will partner with Manufacturing, Quality, EHS, and global teams to drive safe, compliant operations. You will set strategic goals, manage budgets, and lead continuous-improvement initiatives across site operations, while supporting 24/7 manufacturing as needed and mentoring engineering

Qualifications

• Bachelor's degree in engineering is required.
• At least 10 years in biotechnology, pharmaceutical, or related fields.
• Minimum 2 years leading engineering professionals or cross-functional teams.
• Deep experience with GMP validation, manufacturing, engineering or facilities.
• Knowledge of biopharma manufacturing operations, cGMP, GLP, ISO requirements.
• Experience with FDA or regulatory investigations and corrective actions.
• Experience leading GMP validation activities and compliant manufacturing systems.
• Experience with large budgets and complex engineering projects.
• Ability to lead cross-site or cross-functional initiatives.

Responsibilities

• Lead and develop the Manufacturing Engineering function (7–15 staff).
• Ensure reliability, performance, safety, and compliance of equipment and systems.
• Set departmental goals, metrics, and priorities aligned to site objectives.
• Represent engineering in leadership discussions on manufacturing strategy and risks.
• Lead validation strategy, execution, and lifecycle management with QMS alignment.
• Present and defend programs during regulatory audits and inspections.
• Forecast operating and capital needs; oversee the site small-capital portfolio.
• Drive continuous-improvement, upgrades, and reliability enhancements.
• Provide technical direction during critical equipment issues.
• Collaborate with Quality and EHS to maintain validated state.
• Support 24/7 manufacturing operations as needed.
• Coach and develop engineers, promoting accountability and delegation.

Skills

Engineering Leadership

Biopharma Manufacturing

GMP Validation

Regulatory Liaison

Cross-functional Leadership

Education

Bachelor's in Engineering

Job description

Biogen, Inc. seeks an experienced Manufacturing Engineering Lead to guide a 7–15 person team and own the validation, reliability, and optimization of manufacturing process equipment and warehouse technologies.

You will partner with Manufacturing, Quality, EHS, and global teams to drive safe, compliant operations. You will set strategic goals, manage budgets, and lead continuous-improvement initiatives across site operations, while supporting 24/7 manufacturing as needed and mentoring engineering