Project Engineer jobs in United States
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PCI Pharma Services · 9 hours ago

Project Engineer

PCI Pharma Services is a company focused on delivering life-changing therapies and making a global impact. They are seeking a Project Engineer to design packages, processes, and tooling for assembly and packaging pharmaceutical products while ensuring compliance with cGMP and customer requirements.

BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
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H1B Sponsor Likelynote

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. 3 per year
Attend Sales meetings weekly
Develop critical process parameters for assembly and packaging equipment
Interface with material suppliers on process assembly requirements to provide safe and effective assembled and packaged products
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
Attendance to work is an essential function of this position
Other duties as assigned by the supervisor/manager
Adherence to all PCI and cGMP policies, procedures, rules, and regulations
This job has no supervisory responsibilities
This position may require overtime and/or weekend work
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules
Performs other duties as assigned by the Manager/Supervisor

Qualification

FDA-regulated industry experienceProject engineeringProcess engineeringSolidWorks designMathematical skillsComputer skillsMedical device assemblyFollow instructionsThermoformed tooling designCold-formed tooling designPouching tooling designCartoning tooling designBottling tooling designAttention to detailTeamwork

Required

Bachelor's Degree in a related field. Must have a minimum of at least three years of experience in an FDA-regulated industry with a strong preference for 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: Ability to perform more complex computer tasks and knowledge of various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations

Preferred

Ability to demonstrate attention to detail
Drug Delivery medical device
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)

Company

PCI Pharma Services

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PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.

H1B Sponsorship

PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed

Leadership Team

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Gil Valadez
Chief Operating Officer
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Company data provided by crunchbase