Engineering Jobs in Indiana
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Job Title: API EM Quality Assurance Professional
Location: Indianapolis, IN
Duration: 12+ Months Contract (extendable)
Pay Range: $70 - $77 per hour on W2.
Qualifications:
At Client, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Quality Assurance for Quality Control provides support to all QC activities at Contract Manufacturing organizations (CMs). The QA for QC position is essential for ensuring that all QC testing is in accordance with the validated methods and are compliant to cGMPs and regulatory commitments.
Basic Requirements:
• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.
• Additional Preferences:
• Testing experience with Small Molecule
• Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
• Knowledge of pharmaceutical manufacturing operations.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Ability to influence diverse groups and manage relationships.
Education Requirements:
• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
Other Information:
• Must complete required training for API EM Quality Assurance.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must be able to support 24 hour/day operations.
• Up to 20% travel US & OUS.
Responsibilities:
Key Objectives/Deliverables:
• Serve as a liaison between CMs and Client.
• Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.
• Provide quality oversight of CM method validation or method transfer activities
• Escalate quality issues at CMs to Client's QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program.
• Participate in regulatory inspection preparations with CMs.
• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures.
• Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
• Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.
• Participate in APR activities.
• Participate in projects to improve productivity.
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
About the Company
A specialty chemicals organisation is seeking a Sales Representative in Indianapolis, IN to support customers in the pulp and paper, water treatment, and industrial process sectors. The company is committed to sustainability, safety, and delivering innovative chemical and digital solutions that improve customer operations.
Position Summary
The Sales Representative will sell process chemicals such as biocides, defoamers, and related treatments to pulp and paper manufacturing facilities. The role includes providing on-site service, maintaining strong customer relationships, and driving regional sales growth. This position is well suited for a technically minded commercial professional with paper industry or industrial chemical experience.
Key Responsibilities
Customer Management
- Strengthen relationships with key pulp and paper accounts.
- Conduct business reviews and prepare service documentation.
- Provide on-site technical service, troubleshooting, and system checks.
Sales Growth
- Achieve annual sales targets within assigned accounts.
- Identify opportunities to increase chemical use and expand product offerings.
- Prepare forecasts, performance summaries, and market insights.
Process Improvement
- Deliver cost saving and performance enhancing initiatives.
- Recommend appropriate chemical programs to improve runnability and efficiency.
- Support process adjustments and optimise application performance.
Minimum Requirements
- Bachelor’s degree in Pulp and Paper, Chemical Engineering, Chemistry, Biology, or related technical field (preferred)
- Five or more years of relevant industry experience
- Background in pulp and paper, process chemistry, or industrial applications of biocides and defoamers
- Strong technical, commercial, and customer-facing skills
- Solid understanding of business and financial concepts
Job Description
Heartland Food Products Group is a global leader in the consumer-packaged goods (CPG) industry, producing low-calorie sweeteners, coffee, coffee creamers and liquid water enhancers. We manufacture and market Splenda, the #1 brand in the low calorie sweetener category and the most recognized in the world.
We make coffee, tea and water taste better and help people live happier, healthier and longer lives by making it easy to reduce sugar.
We offer an excellent compensation and benefits package. Come grow with us!
This role is not a remote opportunity, it is on-site at our manufacturing plant in Indianapolis, Indiana.
Scope:
The Sr Manager, Quality Systems leads the automation process of our quality systems including the transformation of the quality system to digital and moving to a paperless quality system fully compliant with part 11 of Title 21 of the Code of Federal Regulations. This position ensures compliance to Quality System processes and procedures, Internal and External audits, and Certifications. This includes GMP, Customer Audits, external certifications such as SQF and Kosher, and customer complaint investigations.
Essential Duties and Key Responsibilities:
- Lead and manage the development and implementation of our digital Quality Monitoring Schemes (QMS)
- Lead and manage our continuous improvement program to include leading the Root cause and Corrective Action process (RCA)
- Manage the Consumer Complaint program, to include logging, investigation and reporting of consumer complaints and aging materials as part our continuous improvement program
- Assures compliance to Internal and External Standards. This includes leadership over internal and external Audits and Certifications (GMP and Customer Audits, Certifications such as SQF and Kosher)
- Leads the automation process of the quality system (digital transformation)
- Manage the Consumer Complaint program (logging, investigations and reporting) and manage the aging and hold materials
- All other duties as assigned
QUALIFICATIONS
- Bachelor’s degree in Food Science, Food Engineering, Chemistry or related field with 10 years’ experience is required.
- PCQI Certification, HACCP Certification, experience with GFSI schemes,
- Six Sigma / process improvement experience is preferred
- Strong computer skills and working knowledge of Microsoft Office, Power BI, and computer system architecture principles
- Good communication/interpersonal skills: Interacting with all levels of the organization
- Must be extremely organized, accurate and detail oriented
- Be a critical thinker with significant problem-solving skills and known techniques
- Must be a self-starter with excellent attention to detail
- Food manufacturing experience with knowledge of aseptic and thermal processing
- Strong auditing skills
- Previous leadership experience and experience with management of Quality Systems
- Process improvement skills (e.g. Six Sigma)
- Proficient command of English and strong communication skills required – both verbal and written
- Must have the ability to perform under pressure and communicate well with all departments
Physical Demands:
- Must be able to physically perform the functions of climbing, balancing, stooping, kneeling, crouching, reaching, standing, walking, pushing, pulling, lifting, grasping, feeling, talking, hearing, and repetitive motions
- Must be able to work seated using a computer and phone for long periods of time
- Must be able to work extended hours, such as daily overtime and an occasional weekend
- Must possess visual acuity to document company records
- Continuous walking throughout plant and distribution center
- Lifting up to 40 pounds
Job Summary
We are seeking a skilled Process Technician to support injection molding operations in a manufacturing environment. This role is responsible for mold set-ups, machine start-ups and shutdowns, troubleshooting, and maintaining stable, efficient molding processes.
The Process Technician partners closely with Production, Engineering, Quality, and Maintenance teams to ensure safety, quality, and productivity goals are consistently met. This is a hands-on role ideal for someone who enjoys problem-solving, optimizing processes, and working in a collaborative manufacturing environment.
Key Responsibilities
- Set up, start up, shut down, and pull injection molds according to established procedures
- Troubleshoot molding processes, machines, and auxiliary equipment to resolve quality or efficiency issues
- Monitor and maintain process parameters, cycle times, and product quality
- Support process validations, documentation, and continuous improvement initiatives
- Communicate mold and machine status clearly during shift handoffs
- Partner with Maintenance and Tooling teams to resolve equipment or mold-related issues
- Train and support technicians, operators, and material handlers as needed
- Follow all safety, quality, and production procedures and standards
- Maintain a clean, organized, and safe work environment (5S)
Qualifications
- High school diploma or equivalent
- Experience in an injection molding or plastics manufacturing environment preferred
- Strong mechanical aptitude and technical troubleshooting skills
- Ability to diagnose and resolve molding process issues
- Basic computer skills for documentation and data entry
- Strong communication skills and a team-oriented mindset
- Willingness to learn new processes, equipment, and technologies
referred Experience & Skills
- Injection mold set-up and process optimization experience
- Knowledge of hot runner and cold runner mold systems
- Familiarity with scientific or decoupled molding principles
- Experience working with automation and auxiliary equipment
- Technical training or certifications (RJG or similar) are a plus
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
Position: Mobile Research Unit Operations
Location: Indianapolis, IN with 60-70% travel
Duration: 12-months with likely extension
Pay: $25.00 - $27.00 per hour
Job Description:
The purpose of the Mobile Research Unit (MRU) Operations Lead role is to be the primary point of contact and manage the daily operations of the MRU while deployed at a facility.
Responsibilities:
- Lead and oversee daily on-site processes and operations for the MRU deployment
- Manage set-up and tear-down of Lilly equipment on the MRU and at the facility
- Responsible for proactive IP, consumable and equipment inventory management for MRU at a facility
- Single Lilly liaison at a facility to collaborate with Local Study Coordinator during deployment, while maintaining roles & responsibility alignment that MRU Operations Lead is not a member of the site
- Drive multiple daily cross-functional alignment meetings, immediate resolution and communications with MRU Delivery and Oversight Lead and MRU Operations Project Manager during MRU deployment
- Scheduling and onsite oversight of non-professional staff (security, drivers, etc.) during deployment
- Liaise with Facility staff and leadership as appropriate for any Lilly or MRU specific items
Minimum Qualifications:
- Bachelor’s degree in scientific or health related field
- Willing to travel 70% of time
- Excellent Communication/organizational skills
- Ability to lift 45+ pounds
- Critical Thinking Skills
- There is a lot of troubleshooting with this role so the Leads who will dive in to assess issues and work with the MRU team and Engineering team to resolve these issues
- Communication Skills
- Communication with the MRU team, as well as the clinical team onsite
- Ability to adapt quickly to evolving project requirements and technical challenges. This position is ideal for individuals passionate about advancing scientific knowledge through innovative research methods. We welcome applicants committed to precision, collaboration, and continuous learning. Join us in pushing the boundaries of what is possible in mobile research technology.
Technical Source is partnered with a large pharmaceutical manufacturing client in Lebanon, IN on a major new facility build. They are building out the full asset register for the site and need a junior-level Field/Asset Verification Engineer to help verify and tag 30,000+ pieces of HVAC and facilities equipment.
This is a hands-on, field-focused role – not a traditional validation protocol-writing or protocol-execution position. You’ll spend most of your time in the plant and utility areas, walking down equipment, tagging assets, and entering data.
What You’ll Do
- Walk down HVAC and facilities equipment (mechanical and electrical) throughout the facility.
- Use P&IDs and equipment lists to locate and correctly identify equipment in the field.
- Read and capture nameplate data (manufacturer, model, serial number, ratings, etc.) from equipment.
- Assign and apply asset tags to each verified piece of equipment.
- Enter and maintain equipment information in Excel-based asset data sheets (asset number + nameplate data).
- Potentially use barcode scanners or tablets in the field for tagging and data capture, as project tools are rolled out.
- Support basic problem solving when equipment in the field does not match drawings or existing lists (e.g., mismatched IDs, missing tags), by documenting and escalating discrepancies to the onsite engineering team.
This work is critical in building a complete and accurate asset list that will feed into future maintenance, reliability, and compliance systems for a major pharmaceutical facility.
What We’re Looking For
Must-Have Qualifications
- 1–2+ years of industry experience working around HVAC and/or facilities equipment in industrial, commercial, institutional, or large building environments.
- Examples: manufacturing plants, large commercial buildings, hospitals, universities, data centers, etc.
- Ability to read and use P&IDs (Piping & Instrumentation Diagrams):
- You can use P&IDs and equipment lists to locate and verify equipment in the field.
- Comfortable with field-intensive work and detailed documentation:
- Physically able to walk the site, stand for extended periods, and climb stairs/ladders.
- Comfortable working in plant/utility/roof areas with appropriate PPE.
- Strong attention to detail in capturing and entering technical data into Excel (sorting/filtering, careful data entry).
Designs and manages enterprise data, analytics, and KPI measurement frameworks to deliver reliable and automated performance insights. Acts as a bridge between data engineering and business teams to standardize metrics, develop scalable data models, and enable self-service analytics while improving reporting efficiency through automation and governance of KPI definitions.
The role requires strong expertise in reporting, Microsoft BI, and SQL Server, with working knowledge of statistical tools such as R or Python. Basic familiarity with pharmaceutical industry KPIs is also important to enable faster impact within the domain.
Qualifications:
- Bachelor’s Degree in Engineering, Construction Management, or related field.
- Minimum 10 years’ experience managing major construction projects valued between $500 million and $2 billion, ideally within pharmaceutical, life sciences, or process industries.
- Proven experience working in a client-side leadership capacity on large, technically complex programs in a dynamic and high-pressure environment.
- Deep understanding of construction management systems, progress measurement, and reporting frameworks.
- Strong familiarity with mechanical completion, system turnover, and GMP documentation requirements.
- Demonstrated expertise in construction methodologies for construction sequencing, process equipment, piping systems, HVAC, electrical, and instrumentation installations.
- Excellent communication, coordination, and stakeholder management skills.
- Recognized professional certification (CEng, PMP, MCIOB, or equivalent)
Job Description:
The Construction Lead will provide independent construction quality and compliance oversight and ensure alignment between engineering, construction, and C & Q teams, and reinforces standard work practices across the Project. The Construction Lead will be the point of contact for construction on the project and will report to the Project Director. This position provides oversight of the Construction Management (CM) partner, ensuring disciplined execution, coordination across contractors, and strong field performance from mobilization and early site works through mechanical completion, commissioning support, Qualification and Turnover. This is a 12-month contingent worker role with chance for renewal. The role will act on behalf of the client, ensuring adherence to scope, managing interface issues, and providing early identification of risks and deviations to the Project Manager and Project Director while promoting a culture of safety, quality, collaboration, and performance. The role will ensure the Construction Management (CM) partner have all the necessary input, approvals, and support to enable them to perform their role effectively, efficiently and deliver the project on time and within budget
Responsibilities:
- Review construction plans, schedules, and cost forecasts to confirm alignment with project objectives and delivery milestones.
- Monitor construction cost trends, invoices, and potential change drivers to provide early visibility of risks or deviations.
- Identify construction risks (schedule, cost, quality, safety) and collaborate with Construction Management Partner to develop and implement mitigation strategies.
- Implement and enforce quality standards, ensuring all construction activities are Right First Time, meet design specifications and contractual requirements.
- Lead the team that witness, inspect and verify the quality and compliance of construction work completed.
- Lead site safety performance ensuring safety plans are implemented, conducting inspections, and monitoring compliance with regulatory and OSHA requirements.
- Proactively address non-compliance, performing regular safety walkdowns and quality audits.
- Verify construction completeness and coordinate turnover logistics to support early system completion, documentation readiness, and phased handover in alignment with C&Q-defined readiness criteria.
- Coordinate turnover logistics to support early system completion, documentation readiness, and phased handover, without directing or altering construction sequencing, which remains the responsibility of Construction Management Partner under EPCM execution.
- Coordinate punch list identification and tracking, and escalate unresolved construction and quality deficiencies to the Project Manager.
- Foster a collaborative “one team” culture between Client, Construction Management Partner, subcontractors, and stakeholders.
- Lead Client construction personnel overseeing daily construction activities.
- Act as the primary construction liaison, providing clear, regular progress updates to the Project Manager and PMO Construction Lead and System Owner.
Quality 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. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Quality Engineer.
Job Description:
This Quality Engineer oversees the manufacturing and engineering processes by ensuring the proper use of tools, materials, and procedures to monitor, test and report on the quality of the products. The Quality Engineer is responsible for the generation of a strategic plan to improve the business processes by ensuring compliance of the products and increase production output. The Quality Engineer must be self-directed and must show initiative in identifying and resolving opportunities for improvement, promoting Quality initiatives, and driving continual improvement in the Quality System. The Quality Engineer will pay close attention to detail, must possess analytical/critical thinking/problem-solving skills, possess excellent communication, ethics, math, and interpersonal skills.
Responsibilities:
- Supports efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
- Supports/leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness and leads initiatives to implement corrective action. Promotes use of statistical analysis for determination of improvements and provides analyses to support risk mitigation.
- Implement and monitor all procedures and processes as they relate to Quarantine, Hold, Expired, Damages, Return Goods and Recalled product.
- Evaluate proposed changes for design control requirements. Guides engineering/ manufacturing personnel of appropriate qualification, validation criteria.
- Provides routine analysis of performance indicators and identifies trends. Presents this information to management, supervisors and manufacturing operators. Supports/leads initiatives to improve performance.
- Supports/leads teams to update risk management files for process changes. Focus team on implementing capable processes, process controls, and error-proofing measures.
- Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements and continuous improvement.
- Monitoring the in-process quality check on the line.
- Reviews new Batch records and SOPs.
- Other duties as assigned.
Education and/or Experience:
- BA or BS Degree in Engineering, Quality Control or related field.
- 5 years relevant experience in Quality Engineering/manufacturing/ production processes.
- Familiarity with industrial automation (e.g., distributed control and PLC-based systems)
- Working knowledge of safety, quality systems, and GMPs is required.
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
To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.
