Engineering Jobs in In

222 positions found — Page 4

Food Safety & Quality Senior Manager
✦ New
Salary not disclosed
Indianapolis, Indiana 12 hours ago

A fast‐growing food manufacturer is seeking a Senior Quality Manager / Director to lead the facility's quality and food safety programs. This role oversees quality systems, develops the quality team, and partners with operations to ensure consistent compliance with regulatory, customer, and GFSI standards. The Senior Quality Manager will strengthen processes and drive a culture focused on safety, accuracy, and continuous improvement.

Responsibilities:

- Lead, coach, and develop quality staff; foster a collaborative, accountable culture.

- Own daily execution and improvement of quality systems, including HACCP, FSMA, Food Safety Plans, SPC, and SQF/GFSI programs.

- Ensure compliance with regulatory, certification, and customer requirements; oversee document control.

- Lead internal, external, and regulatory audits, including preparation, on‐site support, and corrective actions.

- Partner with Operations, Sanitation, Maintenance, and R&D to align quality expectations and resolve issues.

- Drive root cause analysis, CAPAs, and continuous improvement initiatives.

- Manage quality metrics, data analysis, and reporting; oversee lab operations, calibrations, and testing accuracy.

Qualifications:

- Bachelor's in Food Science, Microbiology, Engineering, or related field.

- 10+ years of food or beverage manufacturing experience, including 5+ in leadership responsibility. Experience with contract manufacturing, and USDA as well as FDA regulatory compliance is ideal.

- Strong knowledge of GFSI programs; HACCP and PCQI preferred.

- Analytical mindset with experience in statistical tools and quality data systems.

- Excellent communication, leadership, and cross‐functional partnership skills.

If this role aligns with your background and experience, don't wait to apply.

Not Specified
Maintenance Manager
✦ New
Salary not disclosed
Noblesville, Indiana 12 hours ago
Yoh is hiring a Maintenance Manager for our Pharmaceutical Manufacturing client in Noblesville, Indiana. This is a great opportunity to join a growing team!
Summary of Position Responsible for the Safety, Quality and Cost Effectiveness of the maintenance activities within the manufacturing and building facilities operations in their area. Responsibilities include supervising, directing and coordinating the maintenance activities within the area as well as the direct supervision of Maintenance Technicians.
Job Functions:
  • Effectively supervise and guide the maintenance activities of Technicians who are responsible for pharmaceutical production equipment/pharmaceutical facility support equipment and facilities.
  • Conduct maintenance in accordance with FDA guidelines, Good Manufacturing Practices, Controlled Change Management, and all internal and external required regulations pertaining to Good Maintenance Practices.
  • Evaluate and assign work orders to properly skilled technicians. Manage emergency equipment repairs by problem assessment, problem solving and assignment of work to properly skilled technicians.
  • Responsible for the adherence, processing and tracking of maintenance related documentation, including policies/procedures, SOP's, PM/DM reports, deviation reports, change control documents, overdue reports, retired and inactive records, and PM/DM planning schedules.
  • Assist in maintaining accurate maintenance records through an active interface with the computerized maintenance management system (CMMS) during work execution and closeout for work history documentation.
  • Provide training and leadership to direct reports on all daily duties they are assigned with initial and periodic assessments.
  • Manage capital and major maintenance projects within approved dollar limits.
  • Demonstrate knowledge of 5S, TPM and its implementation in an operating environment.
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Requirements
  • B.S degree required. Preferably in Chemical, Mechanical, or Electrical Engineering.
  • 12 or more years of relevant experience in maintenance management and supervision in a pharmaceutical industry required.
  • Extensive knowledge of cGMP, FDA, OSHA, and NRC regulations preferred.

Schedule: Mon – Fri 7am -4pm
Salary: $95 - 130K (DOE)
#IND-SPG
Estimated Min Rate: $95000.00
Estimated Max Rate: $130000.00
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
  • Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
  • Health Savings Account (HSA) (for employees working 20+ hours per week)
  • Life & Disability Insurance (for employees working 20+ hours per week)
  • MetLife Voluntary Benefits
  • Employee Assistance Program (EAP)
  • 401K Retirement Savings Plan
  • Direct Deposit & weekly epayroll
  • Referral Bonus Programs
  • Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice:

Not Specified
Production Maintenance Technician
✦ New
🏢 Yoh, A Day & Zimmermann Company
Salary not disclosed
Noblesville, Indiana 12 hours ago
Yoh is hiring a Production Maintenance Technician for our Pharmaceutical Manufacturing client in Noblesville, Indiana.
Schedule: Saturday - Wednesday, 12AM - 8:30AM, (2 - 4 week training period will be Monday - Friday, 8AM - 4:30PM)
Pay: $22 - 26.50/hr. (DOE)
Type: Contract to Hire
Job Functions:
  • Troubleshoot electrical, hydraulics, pneumatics and mechanical system in an industrial environment.
  • Determines best course of action to make repairs. Sets and/or adjusts priorities to ensure safety and reliability of production equipment and support systems.
  • Test equipment after repairs and leave equipment and area in a clean, safe condition.
  • Perform functionality and alignment checks; make adjustments, modifications, and replacements as directed.
  • Work from schematics, engineering drawings, and written or verbal instructions.
  • Operate related equipment, conduct tests and report data in prescribed format.
  • Use predetermined methods, sequences, and setups to inspect or test specific equipment or product; making modifications and adjustments as necessary.
  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Experience and Education Requirements:
  • Two-year degree in Electrical Automation, Industrial Maintenance, Electronics, Electrical systems, or related field required, or equivalent training in Armed Forces training schools.
  • One or more years of relevant work experience in maintaining, troubleshooting, and repairing industrial equipment and/or automation systems, preferably in pharmaceutical manufacturing equipment.
  • Strong troubleshooting skills, with and without schematics.
  • Use of voltmeter and other general-purpose test equipment
  • AC/DC electrical power systems / supplies (Preferred)
  • Industrial manufacturing equipment, automated systems (Preferred)
  • Automation electronics, electrical controls / PLCs.
  • Proximity and optical sensors, signal wiring / connectivity.
  • AC/DC motors
  • Pneumatics, hydraulics and associated controls.
  • Vacuum pumps / systems
  • Electro-mechanical systems
  • Equipment calibration experience.
  • Building Management Systems
  • Reverse engineering
  • Root Cause Analysis experience.
  • Basic soldering experience.

#IND-SPG
Estimated Min Rate: $22.00
Estimated Max Rate: $26.50
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
  • Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
  • Health Savings Account (HSA) (for employees working 20+ hours per week)
  • Life & Disability Insurance (for employees working 20+ hours per week)
  • MetLife Voluntary Benefits
  • Employee Assistance Program (EAP)
  • 401K Retirement Savings Plan
  • Direct Deposit & weekly epayroll
  • Referral Bonus Programs
  • Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice:

Not Specified
Industrial Designer
✦ New
Salary not disclosed
Hammond, Indiana 12 hours ago

Title: Senior Designer – Oil & Steel Manufacturing

Location: Merrillville, IN (On-site)

Hire Type: Direct Hire

Shift/Hours: Monday–Friday, standard business hours

Base Salary: $85,000 – $115,000 (DOE)

Benefits: Medical, Dental, Vision; PTO; 401(k); Paid Holidays; Career Growth Opportunities

About the Opportunity

An engineering organization is seeking a Senior Designer with experience in oil or steel manufacturing to support complex design projects. This role involves preparing construction documents, developing layouts, performing calculations, and ensuring compliance with client and internal standards. The position offers collaboration with multi-disciplinary teams and exposure to field work, point cloud data, and 3D modeling.

Job Duties

• Complete layouts for projects ranging from simple to complex independently.

• Determine design criteria, drawing sequences, and sectioning for system components.

• Update P&IDs and select or modify standard details.

• Perform calculations, measurements, and prepare material documentation.

• Develop complete discipline drawing packages and ensure compliance with client and internal standards.

• Review and check work of other designers within the discipline.

• Coordinate with project team members to ensure overall project progress.

• Conduct field walkdowns and produce sketches as needed.

Qualifications

• Minimum of 7 years of design experience in the oil or steel manufacturing industries.

• Proficiency in AutoCAD, including 3D modeling.

• Experience working with point cloud scans.

• Strong understanding of design criteria, material specifications, and construction documentation.

• Excellent attention to detail, problem-solving, and team collaboration skills.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national

Not Specified
Project Engineer 4
✦ New
Salary not disclosed
Lafayette, Indiana 12 hours ago

Job Title: Project Engineer 4

Location: Lafayette IN Building B

Notes:

  • For this role, the focus is on maintenance reliability
  • This person will focus on current assets, maintenance data, perform data analysis
  • Lumin – is a software used in this location to run the process
  • Person needs to be familiar with Lumin systems – get data and perform tasks
  • Black belt experience – they will be working on all the assets in the machining space
  • Root cause analysis experience in maintenance space.
  • Basic function or power BI
  • Software : Lumin is of key importance for data analysis in maintenance space (candidate can learn it as well)
  • 7 AM – 4 PM shift
  • Will look at profiles without CNC experience
  • Bachelors and associates are fine with 8 + years of experience
  • Black belt is preferred

Additional stress from Hiring manager:

*maintenance & reliability engineering experience*

1) Maintenance / TPM experience (machining centers process maintenance, not facility maintenance)

2) Statistical & reliability data analytics (statistical data analysis, RCCA, OEE)

3) Power Bi

4) Bachelor's degree in engineering (Mechanical, Electrical, Manufacturing, Industrial) - min 10 years in this space)

  • 5) Llumin CMMS+ (optional)
Not Specified
Solar Designer & Project Developer
✦ New
Salary not disclosed
Indianapolis, Indiana 12 hours ago

Company Description

IKIO is a leading U.S.-based LED lighting manufacturer specializing in Commercial, Industrial, Multi-family Residential/Hospitality, Hazardous Location, and Solar Outdoor applications. Known for its innovative approach and vertically integrated infrastructure, IKIO delivers high-quality, energy-efficient LED lighting solutions and provides services such as lighting audits, power quality improvement, installations, and financing options.

Role Overview

We are seeking a Solar Designer & Project Developer to support the design, development, and execution of solar photovoltaic (PV) projects across residential, commercial, and utility-scale installations in the United States.

This role combines technical system design, project development, permitting coordination, and engineering documentation to ensure solar projects are delivered efficiently, safely, and in compliance with all applicable codes and regulations.

The ideal candidate has strong experience in solar PV system design, engineering software tools, project coordination, and utility interconnection processes.

Key Responsibilities

Solar System Design

  • Design solar photovoltaic (PV) systems for residential, commercial, and industrial applications.
  • Develop site layouts, panel configurations, and system sizing based on project requirements.
  • Perform energy production modeling and shading analysis using solar design software.
  • Create single-line diagrams (SLD), electrical layouts, and construction drawings.

Engineering & Technical Documentation

  • Prepare detailed engineering drawings and technical documentation using CAD software.
  • Conduct system sizing, string calculations, inverter selection, and electrical load analysis.
  • Ensure compliance with NEC, local codes, and utility interconnection requirements.
  • Collaborate with structural engineers for mounting and load calculations.

Project Development

  • Support the development of solar projects from concept to installation readiness.
  • Coordinate utility interconnection applications and permitting documentation.
  • Conduct site feasibility studies and preliminary system layouts.
  • Work with project managers to support project scheduling and execution.

Permitting & Compliance

  • Prepare permit packages for AHJ (Authority Having Jurisdiction) approvals.
  • Coordinate with utilities for interconnection approvals and documentation.
  • Ensure projects comply with local, state, and federal energy regulations.

Collaboration & Coordination

  • Work closely with sales, engineering, procurement, and installation teams.
  • Provide technical support during project installation and commissioning.
  • Review project plans and assist with resolving technical issues.

Required Qualifications

  • Bachelor's degree in Electrical Engineering, Renewable Energy, Mechanical Engineering, or related field.
  • 2–5+ years of experience in solar PV system design or renewable energy projects.
  • Strong understanding of solar PV system components and electrical design principles.
  • Experience with solar design and simulation software.
  • Familiarity with NEC codes and US solar permitting processes.
  • Ability to read and produce technical engineering drawings.

Preferred Skills

Experience with the following tools:

  • Helioscope
  • Aurora Solar
  • PVsyst
  • AutoCAD
  • SketchUp
  • Google Earth / GIS tools
  • Additional certifications preferred:
  • NABCEP PV Associate or PV Installation Professional
  • Professional Engineer (PE) license (preferred but not required)

Key Skills

  • Solar PV system design
  • Energy production modeling
  • Electrical system design
  • Utility interconnection processes
  • Solar permitting
  • Technical documentation
  • Project coordination
  • Problem-solving and analytical skills
Not Specified
Quality Control Scientist
✦ New
Salary not disclosed
Indianapolis, IN 12 hours ago

Details:

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.

Not Specified
Sales Representative - P&P Chemicals
✦ New
Salary not disclosed
Indianapolis, IN 12 hours ago

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
Not Specified
Senior Quality Systems Manager
✦ New
Salary not disclosed
Indianapolis, IN 12 hours ago

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
Not Specified
Cleaning Validation Engineer
✦ New
Salary not disclosed
South Bend, IN 12 hours ago

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

Not Specified
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