Engineering Journal Impact Factor Jobs in None, IN

Build a Career That Matters with One of the World's Most Respected Employers!

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Michelin has an immediate opening for a Safety Professional who will provide support and direction to meet the site's safety, health, and environment objectives. This role is critical in crafting and maintaining a safe environment for our employees and communities. Located in Woodburn, Indiana, our BF Goodrich tire plant produces passenger and light truck tires, contributing to the cultural and economic vitality of northeastern Indiana. If respect for people, teamwork, and trust are values you live by, you should consider joining us!

What Will You Do

• Responds to and coordinates all emergency responses in the plant
• Provides mentorship and direction to Contract Security Services and the Emergency Response Team
• Assists departments in investigating incidents to determine causes and devise preventative measures to minimize recurrence. Assists in preparing incident reports when needed
• Assists in developing and reviewing safety training programs and provides training when requested
• Monitors overall safety of plant operations, including contractors, and provides advice and assistance to line management
• Monitors weather and provides information to plant management on any situation that may affect plant safety or operations
• Monitors and corrects contractor activities to ensure compliance with all safety programs and regulations
• Coordinates hot work and confined space programs
• Monitors all aspects of the fire system, including the alarm system, to ensure it is maintained in working order
• Performs audiometric testing, vision screening, and respirator fit testing as requested

What Will You Bring

• A willingness to work in an industrial plant environment on a rotating 2-2-3, 12-hour shift
• HS diploma or equivalent experience; an Associate's degree in Safety or Emergency Medical Procedures is preferred
• First Aid/CPR or EMR certification required; must complete EMT certification within the first 12 months on the job
• Self-motivated with the ability to work effectively and efficiently under pressure while managing competing demands and tight deadlines
• Cooperative teammate who willingly supports others and collaborates to solve problems
• Ability to influence and communicate effectively with all levels of the organization

Why Michelin?

At Michelin, we believe in providing an environment where our employees can thrive. You will have the opportunity to work with a world-class team dedicated to safety and excellence. We offer competitive compensation and a comprehensive benefits package. Join us and be part of a company that is committed to making a difference in the world!

#LI-HIRINGMICHELIN

Ready to Shape the Future of Innovation?

Michelin is building a world-leading manufacturer of life-changing composites and experiences. Pioneering engineered materials for more than 130 years, Michelin is uniquely positioned to make decisive contributions to human progress and a more sustainable world. Drawing on its deep know-how in polymer composite materials, Michelin is constantly innovating to manufacture high-quality tires and components for critical applications in demanding fields as varied as mobility, construction, aeronautics, low-carbon energies and healthcare.

The care placed in its products and deep customer knowledge inspire Michelin to offer the finest experiences. This spans from providing data- and AI-based connected solutions for professional fleets to recommending outstanding restaurants and hotels curated by the MICHELIN Guide.

Why Michelin?

• Career Growth: Personalized development plans, mentorship, and cross-functional opportunities. Unique career paths and opportunities for advancement.
• Inclusive Culture: Thrive in a diverse, supportive environment where your competencies, contributions and behaviors are recognized. Option to join one of our Business Resource Groups and Inclusion Councils.
• Innovation-Driven: Work on projects that matter-from sustainable materials to digital transformation.
• Community Impact: Be part of a company that does what's right. We use sustainable business practices while balancing the needs of our customers and communities.

Michelin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors. Consistent with these obligations, Michelin also provides reasonable accommodations to employees and applicants with disabilities and for sincerely held religious beliefs. If you need accommodation for any part of the employment process because of a disability, please contact us at .

This position is not available for immigration sponsorship.

We build the future with people like you. Begin your career with Michelin today!

Build a Career That Matters with One of the World's Most Respected Employers!

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This opportunity is in Woodburn, Indiana in our BF Goodrich tire plant. Woodburn is a small town located about 30 minutes east of Fort Wayne, IN. Fort Wayne is the cultural and economic center of northeastern Indiana and the second largest city in Indiana. Established in 1961, our plant makes passenger and light truck tires.

THE OPPORTUNITY

Michelin has an immediate opening for a Shift Manager who leads the shift to achieve performance goals in safety, machine availability, quality, delivery, and cost. This position supports a team on a rotating 12-hour shift schedule.

Michelin's purpose is to support everyone's right to move freely to find their better way forward. This role's purpose is to empower people to provide the best products in the world while helping them grow and achieve their career aspirations. If respect for people, teamwork and trust are some values you live by you should consider joining us, the Worldwide Leader in Tires!

WHAT WILL YOU DO

• Lead and empower a team of production operators to achieve their common objectives on a rotating shift basis.
• Collaborate with maintenance, quality, and other teams to ensure smooth daily operations and meet performance goals.
• Proactively identify and eliminate any obstacles or interferences that may hinder production operations.
• Drive process and team improvements by facilitating their identification and successfully implementing them.
• Coordinate with the supplier of forklift drivers to ensure smooth operations and support to your team.

WHAT WILL YOU BRING

• A willingness to work in an industrial plant environment on a rotating, 12-hour shift schedule.
• Demonstrated experience in leading teams or project groups, setting clear goals, delegating tasks, providing regular feedback and coaching, and promoting a collaborative work environment. Military service experience as a Junior Military Officer or Senior Non-Commission Officer is advantageous.
• Excellent interpersonal skills and the ability to interact professionally with internal partners, suppliers, customers, and colleagues.
• Microsoft Excel data analysis proficiency.

#LI-HIRINGMICHELIN

#LI-SB1

Ready to Shape the Future of Innovation?

Michelin is building a world-leading manufacturer of life-changing composites and experiences. Pioneering engineered materials for more than 130 years, Michelin is uniquely positioned to make decisive contributions to human progress and a more sustainable world. Drawing on its deep know-how in polymer composite materials, Michelin is constantly innovating to manufacture high-quality tires and components for critical applications in demanding fields as varied as mobility, construction, aeronautics, low-carbon energies and healthcare.

The care placed in its products and deep customer knowledge inspire Michelin to offer the finest experiences. This spans from providing data- and AI-based connected solutions for professional fleets to recommending outstanding restaurants and hotels curated by the MICHELIN Guide.

Why Michelin?

• Career Growth: Personalized development plans, mentorship, and cross-functional opportunities. Unique career paths and opportunities for advancement.

• Inclusive Culture: Thrive in a diverse, supportive environment where your competencies, contributions and behaviors are recognized. Option to join one of our Connected Communities.

• Innovation-Driven: Work on projects that matter-from sustainable materials to digital transformation.

• Community Impact: Be part of a company that does what's right. We use sustainable business practices while balancing the needs of our customers and communities.

Michelin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors. Consistent with these obligations, Michelin also provides reasonable accommodations to employees and applicants with disabilities and for sincerely held religious beliefs. If you need accommodation for any part of the employment process because of a disability, please contact us at .

This position is not available for immigration sponsorship.

We build the future with people like you. Begin your career with Michelin today!

Job Title: Estimator – Tool & Die Manufacturing

Salary: $70,000 – $80,000 per year

Bonus: Annual Christmas Bonus

Schedule: Day Shift | Monday–Friday | 7:00 AM – 3:30 PM

We are seeking an experienced Estimator to join a well-established tool and die manufacturing job shop that specializes in precision tooling, molds, fixtures, and dies used in metal and thermoforming production. This is a key role within the organization, responsible for developing accurate project estimates and supporting the sales and engineering teams in preparing competitive quotes for customers.

This position is open due to a retirement, and the outgoing estimator is currently working with the team to ensure a smooth transition and knowledge transfer. The estimator will collaborate closely with engineering, sales, and manufacturing teams to determine the cost, materials, labor, and production requirements for custom tooling projects.

This is an excellent opportunity to join a stable, family-owned manufacturing company where many employees have built long-term careers.

Key Responsibilities

• Prepare accurate cost estimates and quotes for custom tooling, molds, fixtures, and dies.
• Review RFQs, drawings, and project specifications to determine scope, materials, labor, and production requirements.
• Collaborate with engineering, sales, and design teams to gather project requirements such as durability, material specifications, and operating conditions.
• Calculate costs related to: Raw materials (steel, specialty metals, etc.), Labor and machining time, Outsourced processes or third-party services, Shipping and logistics
• Develop detailed proposals and pricing structures for customers.
• Maintain documentation including BOMs (Bill of Materials), cost breakdowns, and pricing data.
• Evaluate project timelines and production requirements to ensure estimates align with manufacturing capabilities.
• Track projects and adjust estimates when production costs or timelines change.
• Support the sales and engineering teams by ensuring quotes are competitive and technically accurate.

Products & Projects May Include

• Tool and die components
• Thermoforming molds
• Foil dies
• Tooling fixtures
• Chucks and collets
• Precision tooling used on press machines and CNC equipment
• Custom tooling for sheet metal production

Required Qualifications

• Experience in estimating or cost analysis within a manufacturing or machine shop environment
• Strong understanding of tooling, fixtures, dies, or metal manufacturing processes
• Ability to read and interpret blueprints and engineering drawings
• Familiarity with Bill of Materials (BOMs) and manufacturing cost breakdowns
• Experience evaluating materials, machining time, labor, and production costs
• Strong collaboration skills with engineering, sales, and production teams

Preferred Experience

• Experience in tool and die, mold making, or machining environments
• Knowledge of steel materials and tooling applications
• Exposure to CNC machining, thermoforming molds, or stamping dies
• Experience using 3D models or CAD drawings during quoting processes

Position Summary

Seeking an experienced Quality Manager to lead, develop, and continuously improve the quality function within a metals manufacturing environment, with a strong focus on cold drawing and roll forming operations. This role is responsible for ensuring products meet or exceed customer requirements and internal quality standards while supporting operational excellence, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

• Develop, implement, and maintain an effective Quality Management System (QMS) aligned with applicable industry standards (e.g., ISO 9001).
• Lead quality assurance and quality control activities supporting cold drawing and roll forming processes, from incoming material inspection through final product release.
• Establish quality objectives, system documentation (procedures, work instructions, control plans), and key quality metrics for critical processes.
• Oversee process monitoring, in-process inspection, statistical process control (SPC), and quality records to ensure consistent and measurable outcomes.
• Lead root cause analysis, corrective and preventive action (CAPA) activities, and structured problem-solving efforts (e.g., 8D, PDCA, DMAIC).
• Partner cross-functionally with Manufacturing, Engineering, Maintenance, and Supply Chain to resolve quality issues and drive continuous improvement.
• Manage customer quality concerns, non-conformances, returns, and supplier quality performance.
• Coach, train, and develop quality team members to ensure consistent application of quality standards and best practices.
• Conduct internal audits, manage calibration programs, and support external audit activities.
• Support new product and process qualification, validation, and change control activities where quality impacts exist.

Required Qualifications

• 5+ years of quality management experience in a manufacturing environment, including cold drawing and roll forming processes.
• Hands-on experience with quality systems, inspection methods, process control, and corrective action programs.
• Strong working knowledge of SPC, measurement systems analysis, and quality performance metrics.
• Ability to read and interpret engineering drawings, specifications, and GD&T.
• Proven problem-solving capability using structured root cause analysis methodologies.
• Demonstrated leadership experience with the ability to develop and mentor a quality team.
• Strong communication, organizational, and cross-functional collaboration skills.

Preferred Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Materials Science, or a related technical field.
• Quality certifications such as Six Sigma (Green/Black Belt), Certified Quality Engineer (CQE), or equivalent.
• Experience implementing and maintaining ISO 9001 quality systems.

Physical & Work Environment

• Ability to work in a manufacturing environment with exposure to noise, industrial equipment, and varying temperatures.
• Occasional lifting of inspection tools and equipment may be required.

About the Company

We improve the safety of patients, clinics, their staff and the environment by transforming the way infection prevention practices are understood and conducted and introducing innovative technologies that deliver improved standards of care. Nanosonics is a company that specializes in the development of innovative solutions for the automated reprocessing of reusable medical devices.

Today, Nanosonics has a global presence with offices across Australia, Canada, the United States of America, Europe, the United Kingdom and Japan. Global HQ is located in Macquarie Park, Sydney, where all Research & Development, Manufacturing and Corporate functions reside. The US Corporate HQ is located in Indianapolis, IN.

About the Role

The Senior Manufacturing Manager is responsible for leading manufacturing and engineering operations at the Nanosonics Indianapolis Manufacturing Site, a chemical packaging facility operating automated mixing and bottling lines.

The role is accountable for safe, compliant, and efficient production while delivering business outcomes for quality, cost, delivery, and performance. The position operates within a global manufacturing model, ensuring alignment with Nanosonics’ standardised and harmonised manufacturing systems and the corporate Quality Management System shared with Australian operations.

This role defines how manufacturing outcomes are achieved locally while delivering what is required by the business.

Responsibilities

Manufacturing Operations

• Own and execute the site production plan, ensuring work orders are released, scheduled, and completed in line with demand, quality requirements, and capacity constraints.
• Lead daily manufacturing operations for automated chemical mixing and bottling lines.
• Ensure production activities are conducted safely, efficiently, and in compliance with approved procedures, specifications, and regulatory requirements.
• Monitor production performance, identify constraints or losses, and drive corrective actions to meet throughput, yield, and delivery targets.
• Ensure effective shift coverage, resource planning, and capability management of Production Team Members.

Engineering Integration

• Provide leadership for engineering support to production, ensuring equipment reliability, process capability, and line performance are maintained.
• Drive continuous improvement initiatives to improve line efficiency, reduce waste, lower COGs, and improve overall equipment effectiveness (OEE) while maintaining product quality.
• Identify, scope, and implement changes to manufacturing processes, equipment, or layouts to improve safety, compliance, capacity, or cost performance.
• Ensure engineering changes are risk-assessed, documented, validated, and implemented without disruption to product quality or regulatory compliance.
• Define and execute site‑level solutions that align with global manufacturing standards, adapting only where local requirements justify deviation.

Work, Health Safety & Environmental Responsibility

• Act as the site leader for Work Health & Safety, ensuring compliance with applicable legislation, standards, and Nanosonics policies.
• Promote a strong safety culture aligned with global Nanosonics expectations.
• Ensure safe handling, storage, mixing, and packaging of chemicals, with appropriate controls, training, and emergency response readiness in place.
• Lead incident investigations, root cause analysis, and implementation of corrective and preventive actions.
• Ensure environmental controls and waste management practices meet regulatory and corporate requirements.

Quality and Compliance

• Ensure the site operates fully within the Nanosonics Quality Management System, recognising that the Indianapolis site operates under the same Quality certification as Australian operations.
• Ensure compliance with GMP, regulatory, and internal quality requirements across all manufacturing and engineering activities.
• Support internal and external audits, inspections, and regulatory engagements.
• Ensure deviations, non‑conformances, and CAPAs related to manufacturing are effectively addressed.

Site Projects and Change Management

• Lead or coordinate cross‑functional projects related to site improvements, compliance upgrades, capacity expansion, or performance enhancement.
• Develop project scopes, timelines, and resource plans aligned with business priorities.
• Ensure changes to processes, equipment, or infrastructure are properly assessed, approved, and implemented.
• Coordinate internal teams and external contractors to deliver projects safely, on time, and within budget.

Leadership & Global Collaboration

• Lead, coach, and develop Production Team Members and Manufacturing Engineers to build capability, accountability, and engagement.
• Set clear expectations and objectives aligned with site and business priorities.
• Build a collaborative working relationship with Australian manufacturing, engineering, and quality teams.
• Act as the primary manufacturing interface between the Indianapolis site and global operations.
• Communicate effectively across time zones to ensure alignment, transparency, and shared accountability.
• Build a high‑performance culture focused on safety, quality, continuous improvement, and operational excellence

Skills and Experience

• Minimum 10 years engineering experience in a highly regulated industry, preferably in medical device or pharmaceutical manufacturing
• 5 years demonstrated experience in leading and developing engineers
• Demonstrated experience in manufacturing engineering and production
• Exceptional communication and stakeholder skills
• Demonstrated experience in delivering solutions that follow best practice problem solving methodology and Lean Manufacturing principles
• Strong engagement and influencing skills across business functions and at senior management levels

Personal Attributes

• Exceptional communication and stakeholder management skills
• Opportunities and solutions focused
• Demonstrate urgency for project timelines and able to clearly communicate these to their team and stakeholders
• Commitment to career long development of themselves and their team
• Exceptional collaboration skills
• Customer focused

Education

• Minimum Bachelor’s degree in Engineering or a related scientific discipline
• Post graduate degree in Engineering or a related scientific discipline desirable
• Management experience of five plus years preferred

What We Offer

• Competitive pay

• Medical, dental, and vision benefits with employer HSA contributions and FSA options

• Immediately vested 401K (US) with company match

• Paid Vacation, Holidays and Sick Time

• Make a difference in your community with 8 hours of Volunteer Paid Time Off each year, giving you the ability to support a cause or organization of your choice.

• Employer-paid short-term disability, long-term disability, and life insurance

• Robust Employee Assistance Program

• Tuition Reimbursement for eligible programs

• Opportunities to expand your skill set and share your knowledge across a ASX publicly traded, global organization

Salary range:

$165,000 to $180,000 annual salary, plus bonus opportunity

Nanosonics is committed to fostering a diverse, inclusive, and equitable workplace where everyone feels valued and respected. We welcome applicants of all backgrounds and strive to ensure equal opportunities in recruitment, development, and advancement. We uphold the principle of equal pay for equal work and actively work to eliminate any unexplainable pay gaps. If you’re passionate about contributing to an environment where diversity thrives, we encourage you to apply.

Kaiser Aluminum is known around the world for its superior quality. Our secret is what we put into it—innovative thinking, industry-leading reliability, and a world-class commitment to customer service. In short, the same qualities we look for in our people. We are looking for an Operational Technology (OT) Engineer to join Kaiser Aluminum Warrick Operations in Newburgh, Indiana!

The OT Engineer ensures that critical manufacturing control systems are reliable and meet the needs of the site, partnering with other manufacturing and engineering teams on projects and initiatives.

As a member of the OT team, you will have the opportunity to manage the complex challenges of scale which are unique to Kaiser Aluminum, while using your technical, process, and business experience to drive operational improvements. The primary responsibilities of the OT Engineer include design, development, deployment, enhancement, and maintenance of process control systems, and optimization of process equipment for maintaining and improving safety, quality, capacity, and reliability in a 7x24 operating environment.

This position is fully on-site and will require a daily in-person presence.

What’s in it for you!

To support our teams and their families beyond the workplace, we provide an outstanding benefits package effective day one of employment!

• Industry leading compensation program.
• 401K options that begin vesting day 1.
• First-rate vacation plan for valuable work-life balance.
• Relocation assistance for new team members.
• Employee resource groups.

What you will work on:

• Control System, Human Machine Interface (HMI), and Data Collection / SCADA systems.
• Process improvement project design and execution
• Industry 4.0 initiatives and projects
• Collaborate with Production, Maintenance, Plant Engineering, Corporate Engineering, IT, and Quality teams to improve process uptime and equipment reliability, through implementation of both new and existing process computer systems
• Partner with Corporate Kaiser Aluminum teams ensuring consistency and enhancement of manufacturing network and domain
• Position includes design, programming, testing, and maintaining systems using the following:
• UNIX/LINUX Operating Systems
• Microsoft Windows Operating System
• Programming in C, VB.NET, FORTRAN
• Citect HMI/SCADA software
• Database Development (SQL and Microsoft Access)
• Basic Network Communications

About you:

Our values – act with integrity, operate with excellence, care for people – are at the foundation of everything we do. To be successful in this role and to play a part in our ongoing success we desire the following background:

• Bachelor’s degree in Engineering or Computer Science
• Recent experience with application development, preferably in support of a manufacturing process control environment
• Excellent problem-solving skills, with a demonstrated ability to understand business needs and leverage technology to meet those needs
• Strong & creative analytical aptitude with high attention to detail and accuracy
• Participation in continuous improvement process improvement opportunities with measurable results that are impactful to the organization

Preferred qualifications:

• Unix, Linux, or other Open Systems administration experience
• SCADA experience
• Familiarity with database concepts, including SQL or similar relational database administration
• Visual Basic, Visual Studio, .NET system experience, web development experience (JavaScript and PHP)
• Desire to work in an industrial environment, working alongside members of the operations teams to understand issues and improve processes

About Kaiser Aluminum Warrick:

We are an equal opportunity employer. All applicants will be considered based on job-related qualifications and abilities. There shall be no discrimination on the basis of age, race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, veteran, or disability status.

Sr. Production Control & Material Operations Manager

**Relocation assistance available

About the Role

We are seeking a Sr. Production Control & Material Operations Manager to lead the coordination, movement, and control of materials throughout a high volume manufacturing facility in the Warsaw, IN area. The successful candidate in this role will oversee production scheduling support, inventory management, inbound material flow, internal logistics, and service parts operations.

The ideal candidate is a hands on leader who thrives in fast moving environments, maintains strong process discipline, and ensures that materials consistently support production requirements.

Key Responsibilities

• Manage day to day material operations, including inventory accuracy, kitting, lineside delivery, warehouse coordination, and service parts fulfillment.
• Lead and develop material operations staff, 3PL partners, and service parts team members while promoting accountability and continuous improvement.
• Ensure all material handling and logistics processes follow safety, quality, and compliance standards.
• Partner with production planning and engineering groups to ensure layouts, equipment, and processes support efficient material flow and throughput.
• Provide timely feedback to planning teams regarding material availability, supplier performance, and schedule impacts.
• Work closely with logistics, receiving, and suppliers to resolve shortages, delays, and discrepancies before they affect production.
• Facilitate daily tier meetings and drive prompt issue resolution to support production stability and takt adherence.
• Maintain BOM accuracy, support incoming inspection activities, and oversee incorporation of engineering changes affecting material flow.
• Collaborate with IT and planning teams to uphold ERP/MRP data integrity and ensure reliable communication between warehouse and shop floor systems.
• Monitor and optimize KPIs such as inventory accuracy, dock to stock time, line shortages, cycle counts, and material handling efficiency.
• Lead material flow improvements, strengthen inventory control practices, and support plant wide continuous improvement initiatives.

Qualifications:

• Bachelor’s degree in Supply Chain, Industrial Engineering, Operations Management, or a related field.
• 8+ years of experience in manufacturing, automotive operations, production control, or materials management.
• Strong working knowledge of ERP/MRP systems (SAP, Oracle, FUUZ, or similar) and MES integration.
• Demonstrated leadership experience in fast paced production environments.
• Excellent communication, analytical, and problem solving abilities.
• Experience with lean manufacturing, JIT, Kanban, and process improvement.
• Familiarity with ISO 9001 or comparable quality management systems.

Apply today for immediate consideration. Qualified candidates will be contacted upon resume review.

Zing Recruiting is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, or any other protected status under federal, state, or local law. We are committed to fostering a diverse and inclusive workplace

JOB TITLE: Mechanical/Electrical Assembly Technician

LOCATION: Indianapolis, IN 46241

INDUSTRY: Manufacturing

JOB DESCRIPTION:

The Electrical/Mechanical Assembly Technician is responsible for assembling mechanical and electrical systems using detailed engineering drawings while ensuring quality, safety, and on-time delivery. The role supports production efficiency and contributes to maintaining a safe and high-quality working environment.

RESPONSIBILITIES:

• Assemble mechanical systems and electrical components according to engineering drawings and production schedules.
• Ensure all assemblies meet required quality standards and tolerances.
• Maintain a safe work environment in compliance with company policies and procedures.
• Support a zero-harm culture related to health, safety, and environmental standards.
• Apply strong workmanship practices to ensure consistent product quality.
• Operate forklift trucks to load, unload, and transport materials within the warehouse.
• Maintain accurate records and documentation with full traceability.
• Identify training needs and collaborate with management to complete necessary training.
• Maintain work areas and equipment to reduce downtime and improve workplace safety.
• Minimize waste and maintain cost-conscious production practices.
• Collaborate with team members to improve performance across safety, quality, delivery, and cost.
• Complete additional reasonable work requests as required.

REQUIREMENTS:

• Minimum 2 years of experience in mechanical fitting or heavy plant production.
• Forklift Truck (FLT) License (training may be provided).
• Welding training or experience
• Ability to read, interpret, and work from detailed engineering drawings while maintaining tolerances and quality standards.
• Proficiency with mechanical fitting tools and equipment, including:
• Bench hand tools
• Electric and compressed-air power tools
• Powered table and pillar tools/machines

ABOUT THEORIS:

Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.

Cleaning Validation Engineer

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Hubot Tri-Pac, Inc South Bend, Indiana, United States (On-site)

Hubot |Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Validation Engineer.

Job Description

The Cleaning Validation Engineer will demonstrate his/her knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes and work independently in a matrix team environment, influencing team decisions, and exercising sound judgement in determining compliant and robust validation approaches. He/she will have the ability to multi-task with a demonstrated track record in meeting deliverable timelines and must demonstrate the ability to think critically and analytically with acumen for troubleshooting and problem solving and is a strong team player aligned with company corporate values. Will have good interpersonal, verbal, and written communication skills and has the ability to function effectively and independently in a fast-paced and dynamic environment. He/she is self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed. Has the ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs. Is an expert with Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills and understands basic statistics, acceptance sampling, and is familiar with statistics software. Demonstrates hands on experience with facility/equipment/utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment and with CIP/SIP cycle development.

Responsibilities

• Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP/SIP qualification), cleaning validation, computer system validation and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis
• As needed coordinate and provide directions to contract personnel performing validation activities
• Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort
• Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports
• Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization) development activities
• Support periodic requalification and revalidation effort
• Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA
• Support gap assessment/closure, corrective actions, and compliance remediation related to Validation
• As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections
• As assigned mentor and manage fulltime validation engineers/specialist and contractors

Education And/or Experience

• Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus
• Minimum 5+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 3 of 7 validation core expertise
• Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation
• Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820)
• Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, and applicable PDA Technical Reports)
• Experience with customer and regulatory inspection
• Strong understanding of quality risk management principles, including best practice in risk-based C&Q approach
• Hands on validation experience in developing validation documentation and field execution
• Project Management experience is a plus
• Aerosol production experience is a plus

Benefits

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

you for your interest and consideration of a career with Tri-Pac, Inc.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer