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Asi Systems Engineering

60 jobs near Columbus, OH

General Atomics

Systems Test Analyst III

Poway, CA · On-site

$89K - $155K/yr

Job Summary General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics ... Collaborates with other engineering members to resolve complex issues and provide feedback for the ...

General Atomics

Engineer III

Poway, CA · On-site

$81K - $141K/yr

Job Summary General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics ... Perform System Engineering activities primarily focused on Unmanned Aircraft related programs.

Autonomous Solutions

Test Engineer/Planner IV

Mendon, UT · On-site

$111K - $130K/yr

Understanding of embedded systems and communication protocols such as CAN, I2C, or SPI * Experience working within functional safety or regulated engineering environments BENEFITS ASI offers a ...

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Sr. Engineering Project Manager - Manufacturing Expansion

ASI Systems Engineering

New Albany, OH • On-site

$80 - $100/hr

Full-time

Posted 11 days ago

Job description

Job Description
Senior Engineering Project Manager - Manufacturing Expansion
Location: Greater Columbus Area, OHContract: 12+ months with strong potential for extensions
Schedule: Full-time, onsite
Industry: Biotech / Pharmaceutical Manufacturing
Automated Systems, Inc. is seeking an experienced Engineering Project Manager to support a major biotech manufacturing expansion in the Greater Columbus Area, Ohio. This is a 300,000 sq. ft expansion for product assembly, packaging, and distribution of medicines, including products used to treat cancer, cardiovascular disease, and autoimmune disease.
This role will provide hands-on project management support for facilities, utilities, process equipment, automation, quality systems, and GMP manufacturing infrastructure associated with the expansion. The successful candidate will work closely with Engineering, Facilities, Manufacturing, Quality, Validation, Construction, and external contractors to drive project execution from planning through installation, commissioning, qualification, turnover, and operational readiness.
This is an excellent opportunity for a strong pharmaceutical or biotech project manager who understands the realities of capital project delivery in a regulated GMP environment: schedule pressure, cross-functional coordination, documentation discipline, quality expectations, and clean hand off to operations.
Key Responsibilities
  • Lead and manage assigned engineering, facilities,utilities, equipment, automation, and GMP infrastructure workstreams forthe New Albany manufacturing expansion.
  • Support execution of a large-scale biotechmanufacturing capital project, including project planning, schedulemanagement, budget tracking, risk management, issue resolution, andmilestone reporting.
  • Coordinate with stakeholders, engineering firms,construction contractors, equipment vendors, CQV teams, Quality Assurance,Manufacturing, Operations, and site leadership.
  • Drive assigned scopes from design review andprocurement through installation, startup, commissioning, qualification,turnover, and operational readiness.
  • Support readiness for GMP manufacturing operations,including punch list closure, turnover packages, qualificationsdocumentation, SOP readiness, and hand off to operations.
  • Track project progress, identify schedule or budgetrisks, escalate issues appropriately, and drive practical resolution.
  • Ensure project activities are executed in accordancewith applicable GMP requirements, engineering standards, site procedures,safety requirements, and quality expectations.
  • Prepare and present project status updates for clientleadership and cross-functional project teams.
  • Support change management, documentation control, fieldcoordination, and alignment between engineering execution andvalidation/quality requirements.
  • Help ensure a disciplined transition from constructionand project execution into validated, compliant, operational manufacturingcapability.

Requirements
Required Qualifications
  • Bachelor's degree in Engineering, ConstructionManagement, Life Sciences, or a related technical field; equivalentexperience will also be considered.
  • Significant senior level experience managing engineering,facilities, utilities, capital, automation, or manufacturing projects in apharmaceutical, biotech, medical device, or regulated manufacturingenvironment.
  • Strong understanding of GMP project execution,including commissioning, qualification, validation, quality documentation,turnover, and operational readiness.
  • Demonstrated ability to manage multiple stakeholders,vendors, contractors, and internal project teams.
  • Strong schedule, budget, resources, risk, and issuemanagement skills.
  • Excellent written and verbal communication skills,including the ability to provide clear executive-level project updates.
  • Ability to work effectively onsite in a fast-movingcapital project environment.
  • Proficiency with project management tools such as MSProject, Primavera P6, Smartsheet, Excel, PowerPoint, or similarplatforms.

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