Product Launch & Lifecycle Engineer III/IV - Aseptic Processing / Sterile Manufacturing

Boehringer Ingelheim; Columbus (OH); On-site; USD 85,000 - 115,000; Full time

Job summary

Boehringer Ingelheim is looking for a Product Launch & Lifecycle Engineer based in Columbus, OH. The role combines technical leadership in pharmaceutical processes and product lifecycle management. You will be instrumental in ensuring product availability and working closely with cross-functional teams.

The ideal candidate has extensive experience in engineering within the pharmaceutical sector, with a strong focus on regulatory compliance and quality assurance, along with the ability to mentor peers and lead impactful projects.

Qualifications

• Minimum 10-15 years in pharmaceutical process or packaging engineering.
• Working knowledge of experimental methodology.
• Proficient in problem identification and root-cause analysis.

Responsibilities

• Ensure continuous availability of Boehringer Ingelheim products.
• Manage lifecycle changes and support cross-functional teams.
• Provide technical leadership for aseptic processing and sterile manufacturing.

Skills

Process validation

Project management

Technical leadership

Communication skills

Problem-solving

Data analysis

Microsoft Office proficiency

Education

B.S. degree in Chemistry, Engineering, Pharmacy or related scientific discipline

Job description

Product Launch & Lifecycle Engineer

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides an opportunity for all employees to collaborate internationally, offering visibility and the chance to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work–life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The role is based on site at our Columbus, OH location with hybrid flexibility of 2–3 days per week on site.

Duties & Responsibilities

• Ensures availability of Boehringer Ingelheim products throughout lifecycle; provides lifecycle support (process and packaging expertise) for Human Pharma, Animal Health and BIO products produced in the US or imported for the US market.
• Manages and supports cross‑functional teams to implement product lifecycle changes and ensure continued market supply.
• Manages Continued Process Verification, Control Strategy Summary and Transport Qualification processes to monitor product performance.
• Coordinates continuous improvement activities for launched products through initial commercial production and across lifecycle.
• Supports Third‑Party Quality and Commercial Quality by providing technical and operational expertise in evaluation of events, deviations and complaint investigations affecting US marketed products.
• Identifies product quality, process and packaging robustness optimisation opportunities through analysis of product performance and collaboration with internal and customer groups.
• Collaborates with regulatory affairs to assess regulatory impact of potential product changes and ensure compliance.
• Prepares and/or reviews line trial/validation protocols, master batch records, product or packaging material specifications, master packaging specifications, labeling technical elements and other documents to meet published timelines.
• Works with development partners (Boehringer sites, external CMOs) for process and packaging development, registration of new product authorizations and knowledge transfer to commercial operations.
• Provides critical review of new products, processes and packaging regarding fit with US operational capabilities and recommends optimisation opportunities.
• Executes assigned project deliverables with minimal guidance; provides problem‑solving for medium‑to‑high complexity issues.

Aseptic Processing & Sterile Manufacturing

• Provides technical leadership for aseptic processing and sterile manufacturing systems, including filling operations, environmental monitoring and contamination control strategies.
• Supports process validation, media fill readiness and inspection readiness activities.
• Ensures compatibility of process and packaging systems with cleanroom environments and sterile handling requirements.
• Identifies and mitigates risks related to aseptic process robustness, contamination control and operator/environmental interactions.

Requirements

• B.S. degree in Chemistry, Engineering, Pharmacy or related scientific discipline.
• Level IV: Minimum 15 years in pharmaceutical process or packaging engineering, quality assurance, product development, manufacturing or related experience; or 20 years of related industry experience.
• Level III: Minimum 10 years in pharmaceutical process or packaging engineering, quality assurance, product development or manufacturing; 12 years of related industry experience.
• Working knowledge of experimental methodology and design of experiments.
• Ability to define root‑cause relationships, collect data, establish facts and draw valid conclusions.
• Ability to apply PDCA principles.
• Demonstrated ability to learn functionality and troubleshooting of pharmaceutical manufacturing equipment and understanding of critical equipment parameters.
• Proficient computer skills with Microsoft Office.
• Organizational and project‑management skills.
• Works under direct supervision for strategic decisions; minimal supervision for tactical execution of moderate complexity tasks.
• Active participant and occasional facilitator on teams of moderate to high complexity.
• Strong communication skills to educate colleagues on technical principles.
• Business acumen and investigative techniques to uncover problem areas and recommend corrective actions.

Desired Skills, Experience and Abilities

• Performs process, packaging or transport risk assessments; identifies critical risk areas and remediation plans.
• Back‑up/surge capacity for Product Launch Manager role.
• Leads cross‑functional teams in design and execution of new product launch plans.
• Mentors and cross‑trains other engineers in technical and procedural aspects of launch and lifecycle management.
• Coordinates directly with peers in corporate functions and production sites to share knowledge and best practices.

Eligibility Requirements

• Legally authorized to work in the United States without restrictions.
• Willing to take a drug test and post‑offer physical if required.
• Must be 18 years of age or older.