Investigator I / II

Biogen; North Carolina; On-site; USD 69,000 - 111,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Disability Insurance

Paid vacation and year-end shutdown

Holidays + personal days

Sick time

Parental leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen is seeking an Investigator in North Carolina to lead investigations into quality deviations and safety events across manufacturing operations. You will conduct interviews, analyze data, and develop CAPAs to reduce recurrence while ensuring compliance with QMS and regulatory expectations.

The role collaborates across functions and supports audits and continuous improvement. The position emphasizes structured problem solving, strong writing, and stakeholder management in a regulated

Qualifications

• Experience conducting investigations, root cause analyses, or operational problem-solving activities within regulated environments.
• Strong analytical and critical thinking skills with the ability to evaluate complex information and develop practical solutions.
• Excellent technical writing and documentation abilities.
• Strong facilitation, communication, and stakeholder management skills.
• Ability to effectively collaborate across multiple functions and levels of the organization.
• Working knowledge of quality systems, safety programs, and compliance requirements within manufacturing, laboratory, industrial, or regulated environments.
• Demonstrated ability to manage multiple priorities and meet critical deadlines.

Responsibilities

• Lead investigations for quality deviations, safety incidents, alert actions, and remedial action requests across manufacturing operations
• Conduct interviews, gather and analyze data, facilitate investigation meetings, and apply systematic cause analysis methodologies to identify root and contributing causes
• Author clear, concise, and compliant investigation reports within designated quality and safety systems
• Partner with cross-functional stakeholders to develop effective corrective and preventive actions (CAPAs) that reduce recurrence risk
• Ensure investigations are completed in alignment with Quality Management System (QMS) requirements, regulatory expectations, and established timelines
• Share investigative findings and lessons learned across the organization to drive continuous improvement and operational excellence
• Support complex and high-impact investigations as needed
• Present investigation outcomes and supporting documentation during internal and external audits

Job description

Job Description

As an Investigator within Human Performance & Investigations, you will play a critical role in strengthening operational excellence by leading investigations into quality and safety events across our manufacturing organization. You will apply structured root cause analysis methodologies and Human & Organizational Performance (HOP) principles to identify opportunities for improvement, reduce recurrence risk, and enhance operational reliability. This role offers the opportunity to partner across manufacturing, quality, engineering, environmental health & safety, and site leadership teams to drive meaningful organizational learning and performance improvements.

Shift details: Monday-Friday. There is flexibility to work from 8 am to 5 pm or 7 am to 4 pm. There may be an occasional need for weekend and after-hours support.

What You’ll Do

• Lead investigations for quality deviations, safety incidents, alert actions, and remedial action requests across manufacturing operations
• Conduct interviews, gather and analyze data, facilitate investigation meetings, and apply systematic cause analysis methodologies to identify root and contributing causes
• Author clear, concise, and compliant investigation reports within designated quality and safety systems
• Partner with cross-functional stakeholders to develop effective corrective and preventive actions (CAPAs) that reduce recurrence risk
• Ensure investigations are completed in alignment with Quality Management System (QMS) requirements, regulatory expectations, and established timelines
• Share investigative findings and lessons learned across the organization to drive continuous improvement and operational excellence
• Support complex and high-impact investigations as needed
• Present investigation outcomes and supporting documentation during internal and external audits

Who You Are

You are a curious problem solver who enjoys uncovering the underlying causes of complex operational events. You are skilled at facilitating discussions, gathering insights from multiple stakeholders, and translating technical information into actionable recommendations. You thrive in a collaborative environment and are motivated by improving systems, processes, and organizational performance.

Required Skills for an Investigator I : Pay Range $69,000 - $90,000

• The following combination of academic and/or relevant experience may be considered:
  • Bachelor’s degree from an accredited college or university, STEM preferred
  • Associate’s degree, STEM preferred and at minimum 2 years of direct experience
  • A High School Diploma (or equivalent) and at minimum of 4 years of direct experience
• Experience conducting investigations, root cause analyses, or operational problem-solving activities within regulated environments
• Strong analytical and critical thinking skills with the ability to evaluate complex information and develop practical solutions
• Excellent technical writing and documentation abilities
• Strong facilitation, communication, and stakeholder management skills
• Ability to effectively collaborate across multiple functions and levels of the organization
• Working knowledge of quality systems, safety programs, and compliance requirements within manufacturing, laboratory, industrial, or regulated environments
• Demonstrated ability to manage multiple priorities and meet critical deadlines

Required Skills for an Investigator II: Pay Range $85,000 - $111,000

• The following combination of academic and/or relevant experience may be considered:
  • Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience
  • Associate’s degree, STEM preferred and at minimum 4 years of direct experience
  • A High School Diploma (or equivalent) and at minimum of 6 years of direct experience
• Experience conducting investigations, root cause analyses, or operational problem-solving activities within regulated environments
• Strong analytical and critical thinking skills with the ability to evaluate complex information and develop practical solutions
• Excellent technical writing and documentation abilities
• Strong facilitation, communication, and stakeholder management skills
• Ability to effectively collaborate across multiple functions and levels of the organization
• Working knowledge of quality systems, safety programs, and compliance requirements within manufacturing, laboratory, industrial, or regulated environments
• Demonstrated ability to manage multiple priorities and meet critical deadlines

Preferred Skills

• Experience with Human & Organizational Performance (HOP) principles
• Knowledge of systematic cause analysis methodologies such as Event & Causal Factor Charting, Logic Fault Tree Analysis, or similar techniques
• Experience supporting manufacturing, pharmaceutical, biotechnology, chemical, industrial, or other highly regulated operations
• Knowledge of cGMP, cGLP, OSHA, EMA, FDA, or similar regulatory requirementsExperience participating in regulatory inspections or audits
• Experience participating in regulatory inspections or audits

Job Level: Professional

Additional Information

The base compensation range for this role is: $85,000.00-$110,500.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.