GForce Life Sciences Jobs (2)

Summary Our client, a Fortune 500 Medical Device Company, has engaged GForce Life Sciences to provide a Manager, Equipment Maintenance.

This position will report to a Sr. Manager, Engineering within the engineering department. This individual will be responsible for leading the manufacturing engineering group and the maintenance engineering & maintenance technical group, as well as be responsible for the installation, maintenance, calibration and troubleshooting of all manufacturing equipment.

This individual will also be responsible for developing strategies to detect and prevent issues that affect safety, quality, and throughput.

This position requires someone to take ownership of the operation engineering plan to improve production processes, upgrades in equipment / layout changes to optimize production flow and efficiency, expand capacity to support growth, and product quality improvements to achieve production of safe, effective, and compliant IVD and RUO instrumentation.

They will take ownership of the development and execution of validation protocols (IQ / OQ / PQ / PV) for production equipment,laboratory equipment, utilities, and other related systems in an FDA regulated environment, as needed.

They will Partner with R&D as part of manufacturing transfer and scale up for new product introductions and engage with manufacturing teams to find opportunities and provide improved production capabilities.

Duties / Expectations of Role Responsible for carrying out capital projects, engineering design, development of specifications, defining scope of work, project planning and execution, as well as organizing and coordinating resources and budgets.

Align manufacturing engineering, maintenance engineering, and maintenance technician support to match production schedules.

Ensure engineering sustains effective engagement with the design transfer groups of new and changed product development, validation, and market release phases.

For new product / process designs the manager is responsible for providing technical input to ensure product and systems are designed with safety, quality, scalability, and sustainability as a top priority.

Lead the industrialization of current and new processes. This includes lean process area design, development of process / production metrics and targets, visual management systems, etc.

Responsible for implementing robust change management systems to detect changes, control changes, and document changes made to the process and / or the equipment to protect validated state’.

Perform capacity, equipment efficiency, and labor utilization analysis to optimize manufacturing processes. Identify opportunities for business process improvements and efficiencies.

Maintain schedules for all GMP systems / lab equipment to ensure that they are requalified / revalidated / calibrated on time.

Responsible for the implementation and management of asset performance metrics (MTBF, MTRR, MTTF, OEE, etc) and visual management of KPIs.

Mandatory Requirements Bachelor’s degree in mechanical, electrical, or industrial engineering related discipline. 8+ years of manufacturing engineering, process engineering, maintenance engineering and / or product transfer focused operations experience in a relevant ISO 13485 and / or FDA regulated industry setting.

2+ years of leadership experience with direct management of teams 2+ years of experience with electromechanical assembly manufacturing 1+ years of experience with optical designs and calibration Thorough knowledge of ISO 13485 and design control requirements as defined by the FDA quality system guidelines.

PLC programming Nice to Have Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments.

Proficiency in enterprise resource planning and manufacturing execution systems. Working knowledge of cost accounting. Term & Start Permanent role Start date ASAP- 2 weeks from an offer Full time, 40 hours a week Onsite, Northbrook, IL Travel 10%, domestic Benefits included : Medical, Dental, Vision, 401k, PTO Two interviews Powered by JazzHR

Summary

Our client, a Fortune 500 Pharmaceutical Company , has engaged GForce Life Sciences to provide a Capital Projects Project Manager .

This position will report to an Associate DirectorFacilities Project Management.. This individual will be responsible for providing leadership in planning, budgeting, and overall management of major capital projects and initiatives from conceptualization through design, bidding, construction, commissioning, and close out .

This position requires the ability to use project management tools and techniques, core focus areas include defining and meeting project goals, budget, schedule, scope, quality, risk mitigation and responding to field conditions and construction logistics and challenges

This position will lead multiple high-complexity projects of diverse scope that require an understanding of current business trends, construction techniques, innovative project delivery methods, thorough knowledge of HVAC, mechanical, electrical, plumbing, fire protection, as well as rigor in compliance, and the highest standard of care.

Duties / Expectations of Role

• Develops well-conceived and timely project plans that outline and map the overall project process and breaks critical focus areas that provide detailed, well-informed roadmaps and risk aversion planning
• Builds tracking and reporting platforms that integrates into the ED&C project financial and engineering controls system
• Performs all project management duties for major new construction, renovation, infrastructure, research laboratories and facilities related projects using mastery of domain knowledge and extensive business experience
• Supports and incorporates ED&C Quality Management standards and processes
• Performs all required due diligence activities and ensures responsive incorporation of findings and tracking of risk issues
• Monitors design and construction activities to ensure that all phases of work are done in accordance with corporate standards and contractual agreements that is compliant to schedule and budget requirements.
• Establishes and maintains highly complex project budgets, cash flow analyses, and cost estimates, as well as reviews purchase orders, change orders, and invoices with significant impact on the success of company operations
• Identifies and addresses areas of concern regarding potential liabilities and risks.
• Develops, monitors, and maintains project schedules; ensures that project objectives with regard to time are met. Maintains client, consultant, contractor, and vendor relationships;

manages conflict resolution.

• Communicates highly complex ideas, anticipates potential objections and persuades others, often at executive leadership levels, to adopt a different point of view
• Evaluates, develops and selects standards, tools, and knowledge requirements for Facilities Project Management skills and career development.
• Collaborates with End Users, Project Stakeholders, Department Heads and key decision makers to ensure compliance to project goals and the management of expectations

Mandatory Requirements

• Bachelors Degree in Architecture, Engineering or Construction Management
• 8+ years of Project Management / Construction Management
• Minimum of $25 million in construction completed
• Major research laboratory Project and infrastructure project experience preferred
• Experience, knowledge, and a track record in project management techniques,concepts, principles, and standards.
• Proficient in advanced techniques with relevant software.
• High proficiency with general Microsoft applications, including MS Project and Share Point. Experience with project management applications.
• Architectural or Engineering background with planning, design, construction administration, compliance, and infrastructure system understanding.
• Anticipates business and industry issues; recommends product, process or service improvements

Nice to Have

Masters Degree in Architecture, Engineering or Construction Management

Term & Start

• 12 Month Contract with the possibility of becoming full time
• ASAP
• Full time salaried Consultant
• Hybrid
• 25-50% Travel including international travel
• Benefits included (Medical, Dental, Vision, 401k)