Project Engineer- ADD

About the position

The Assembly Project Engineer at PCI is responsible for designing packages, processes, and tooling for assembly and packaging pharmaceutical products. The role ensures that products are packaged consistently and comply with cGMP's and customer requirements. The engineer will work on various tasks including quoting tooling and processes, tracking project costs, designing assembly layouts, and acting as a technical Subject Matter Expert (SME) during customer project meetings. The position requires adherence to PCI and cGMP policies and may involve overtime or weekend work.

Responsibilities

• Quote tooling and processes for existing or new equipment weekly.
• Track tooling and equipment project costs versus planned expenditure.
• Design assembly and package line layouts for pharmaceutical products weekly.
• Design/purchase tooling for Assembly and packaging equipment weekly.
• Act as technical Subject Matter Expert (SME) to support customer project team meetings weekly.
• Write/revise and execute vendor Factory Acceptance tests as required.
• Attend Sales meetings weekly.
• Develop critical process parameters for assembly and packaging equipment.
• Interface with material suppliers on process assembly requirements.
• Design and implement parts and processes for line improvements monthly.
• Provide information on product contact materials and validation support weekly.
• Attend and support customer conference calls weekly.
• Review and approve batch records for engineering details weekly.
• Adhere to all PCI and cGMP policies, procedures, rules, and regulations.
• Perform other duties as assigned by the Manager/Supervisor.

Requirements

• Bachelor's Degree in a related field.
• Minimum of at least three years of experience in an FDA-regulated industry, preferably in medical devices or combination products.
• Minimum 3-5 years of related experience and/or training in project and process engineering roles.
• College-Level Mathematical Skills.
• Intermediate Computer Skills.
• Full Professional Proficiency in English.
• Intermediate Reasoning skills.

Nice-to-haves

• Ability to demonstrate attention to detail.
• Experience with Drug Delivery medical devices.
• Ability to travel.
• Ability to work independently and/or as part of a team.
• Ability to follow instructions and respond to management direction.
• Design in SolidWorks is a major requirement; AutoCAD design work is a plus.
• Previous medical device assembly experience.
• Design of thermoformed or cold-formed blister tooling, pouching tooling, cartoning tooling, and/or bottling tooling is a plus.

Benefits

• Paid time off
• Health insurance coverage (including dental and vision)
• Flexible spending account
• 401(k)
• Annual performance bonus eligibility