SR Principal Engineer, Packaging

Boehringer Ingelheim; Barceloneta (PR); On-site; USD 110,000 - 150,000; Full time

Job summary

Boehringer Ingelheim is seeking a Subject Matter Technical Expert for Packaging to drive packaging strategy on site across the product lifecycle. You will lead technical assessments, evaluate changes, and collaborate with Global Innovation and Regulatory teams to ensure compliance and quality.

The role requires a engineering degree with 5+ years in pharma packaging, plus knowledge of GMP, process development, and agile project leadership. Domestic and international travel may be required.

Qualifications

• Bachelor's degree in Engineering or related field.
• Master’s degree in Packaging or Polymers preferred.
• Project management/Lean/Agile qualifications desired.

Responsibilities

• Provide technical expertise for Packaging on site throughout product life cycle and guidance to Global Innovation during development.
• Evaluate and approve moderate and major change requests autonomously.
• Analyze complex process/product data and prepare reports autonomously.
• Provide troubleshooting and scientific guidance for technical transfers, deviations, validations, and tests.
• Support questions from Regulatory Authorities in various regulatory processes.
• Develop technical solutions for process optimization and cost of goods impact.
• Lead cross-functional streams / projects aligned with project management methodology.

Skills

Fluent English

Agile Management

Education

Bachelor's degree in Engineering

Master's degree in Packaging or Polymers (preferred)

Job description

Description

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 opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of 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.

Subject Matter Technical Expert for Packaging on site for analysis and guidance throughout product / process life cycle and/or guidance to Global Innovation during new product development. Deliver projects on alternative packaging material suppliers, optimize designs and materials to increase line performance and adequate to sustainability and agencies’ standards, perform troubleshooting on the shop-floor and develop suppliers according to site needs.

Duties & Responsibilities

• Provide technical expertise for all Packaging matters on site including analysis and guidance throughout product / process life cycle and/or guidance to Global Innovation during new product development.
• Evaluate and approve moderate and major change request autonomously.
• Analyze complex process / product data and prepare reports autonomously.
• Provide troubleshooting, root cause analysis and scientific guidance autonomously for execution of technical transfer, manufacturing deviations, validations, analytical tests, etc.
• Provide technical input and support for questions received from Regulatory Authorities in various regulatory processes, e. g. geographical expansion of existing products, post approval changes on existing registrations.
• Develop technical solutions for process optimization/ improvement and evaluate possible impact on cost of goods.
• Recommend new technologies to support future definition of innovative manufacturing platforms.
• Provide scientific guidance on existing BIAH technologies to guide definition of Technology Standards.
• Support of technical Position Papers for MSAT Organization.
• Autonomously seek out new technologies for potential use in existing or new manufacturing processes.
• Autonomously research and recommend future-oriented Technology Platforms.
• Facilitate, distill and integrate information into technical body of knowledge for BIAH products and processes.
• Continually develop and maintain an appropriate individual level of theoretical and practical expertise to respond to the needs of BIAH
• Facilitate and distill ongoing product / process knowledge within global and local MSAT teams.
• Execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader or Project Contributor.
• Provide technical guidance and recommendations for user requirements, product or process changes.
• Develop, structure and lead cross-functional streams / projects / programs aligned with project management methodology.
• Propose and manage scope, budget, schedule, and associated risks to deliver fully-functional deliverables / projects meeting Customer requirements.
• Ensure compliance to regulatory requirements and BI / external standards (EHS, VICH, Corporate procedures, GxP etc.).
• Establish & maintain communication tools (e.g. project charter, monthly reports) to effectively communicate with all relevant stakeholders.
• Ensure and measure customer satisfaction along the project life cycle.

Requirements

• Bachelor's degree in Engineering or related field with 5+ years of experience in pharmaceutical industry. Master’s (Packaging or Polymers) preferred with 3 years of experience in the pharmaceutical industry.
• Additional qualification in project management (Lean, agility) is desired.
• Expertise in novel technologies or sciences is desired.
• Expertise in packaging materials, packaging functionalities, packaging processes
• Thorough understanding and process knowledge of o Pharmaceutical Quality System -Good Manufacturing Practice (GMP) -New product development and product lifecycle management processes
• Demonstrated technical expertise at bench and production scale
• Fluency in English required – additional language skills are desired
• Willingness to travel domestically and internationally
• Demonstrated international/intercultural collaboration
• Training and leadership in Agile Management preferred
• Proven and demonstrated specialized/depth of knowledge and leadership in identified discipline

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.