We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Principal Engineer, Packaging Equipment
Position Summary
The Principal Engineer, Packaging Equipment is responsible for providing technical expertise in the design, development, qualification, and validation of packaging equipment, processes, systems, and components.
The individual will provide technical leadership for packaging equipment while collaborating with Manufacturing, Operations, Research & Development, Marketing, Market Research, Supply Chain, Process Excellence, and other affiliated functions to identify and address packaging equipment and/or validation needs.
The role may also include coordination and oversight of packaging equipment engineers, packaging validation engineers, and/or contractors.
Key Responsibilities
- Plan and execute multiple and/or key packaging equipment and validation assignments, including lifecycle management initiatives, and develop risk-mitigation strategies to support project commitments.
- Lead and improve packaging processes and equipment technologies, including initiatives that may be implemented across multiple locations.
- Lead, develop, and execute packaging equipment and validation strategies.
- Assess existing equipment limitations and develop technical solutions to eliminate technical or operational roadblocks.
- Identify and evaluate new packaging equipment technologies and packaging processes.
- Provide engineering solutions, technical advice, and support to Manufacturing and other departments as required.
- Develop and execute plans to maintain and improve Overall Equipment Effectiveness (OEE) at packaging sites.
- Identify and execute opportunities to improve compliance, quality, efficiency, and cost.
- Support and/or lead the development and assessment of:
- Design requirements
- Scope of change
- Packaging and equipment solution proposals
- Prior-knowledge and knowledge-gap assessments
- Risk assessments
- Test plans
- Test results analysis and conclusions
- Develop, write, align cross-functionally, and route for approval packaging equipment specifications and project documentation.
- Develop and/or support documentation including:
- User Requirement Specifications (URS)
- System Design Specifications (SDS)
- Line layouts
- Factory Acceptance Tests (FAT)
- Site Acceptance Tests (SAT)
- Commissioning and Qualification plans and protocols
- Packaging line trial protocols and reports
- Risk assessments
- Lead the development and alignment of packaging equipment qualification documentation.
- Support and/or lead execution of line trials, engineering studies, process qualification, and process performance qualification.
- Identify and propose technical solutions, innovations, or optimization opportunities with significant operational impact.
- Contribute to or lead specific elements of capital planning, project submissions, and management reviews.
- Lead or consult on equipment- and process-related investigations and significant technical challenges.
- Apply structured problem-solving methodologies and advanced data-analysis techniques to identify and resolve root causes.
- Author, review, or oversee technical investigation reports as required.
- Support the selection and management of contractors and ensure assigned activities are performed safely and efficiently.
- Apply Project Management principles and methodologies to support effective project execution.
- Ensure project activities comply with applicable company policies, procedures, Quality requirements, Environmental Health & Safety standards, regulatory requirements, and industry standards.
Education
- Bachelor's degree in Engineering or a technical field required.
- Advanced degree preferred.
Experience
- 8+ years of GMP experience within the consumer, OTC, or pharmaceutical industry.
- Extensive and diversified technical knowledge related to manufacturing equipment, processes, and materials.
- Experience working within a highly regulated environment preferred.
- 6+ years of deep technical knowledge in one or more of the following:
- Packaging equipment
- Liquid compounding and processing
- Filling equipment
- Equipment qualification
- Equipment validation
- Specific equipment knowledge involving:
- Fillers
- Labelers
- Cartoners
- Case packers
- Palletizing equipment
- Robotics
- Automation
Knowledge, Skills & Abilities
- Ability to work effectively within cross-functional and cross-company environments.
- Demonstrated ability to manage major project activities and multiple contractors.
- Strong understanding of engineering principles and regulatory/compliance requirements.
- Ability to apply engineering and scientific principles to resolve complex or unprecedented technical challenges.
- Ability to communicate complex technical information clearly and concisely.
- Ability to critically analyze engineering drawings and technical documentation.
- Strong leadership, analytical, and independent working capabilities.
- Ability to apply structured problem-solving methodologies.
- Experience with Process Excellence, Six Sigma, Lean, or similar methodologies preferred.
- Proficiency with Microsoft Office applications, particularly Excel, PowerPoint, and Microsoft Project or equivalent.
- Experience with vendor and contractor management, including:
- Bid requirement preparation
- Bid comparisons
- Schedule/timing tracking
- Additional Requirements
- Ability to provide technical and team leadership for project and departmental initiatives.
- Strong accountability for assigned work and outcomes.
- Ability to represent the engineering function with project teams, cross-functional groups, external partners, suppliers, and contractors.
- Strong results orientation and sense of urgency.
- Effective communication across all levels of an organization.
- Ability to mentor and provide technical guidance to less experienced engineers.
- Commitment to quality, compliance, required training, established procedures, and applicable EHS requirements.
- May require up to 25% travel based on business needs.
