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Validation Engineer

Contract: 6+ month duration with potential for extensions

Location: Woodstock, IL - ONSITE

Shift: First-shift hours; flexibility to support project timelines required

Industry: Sterile Liquids Manufacturing

Automated Systems, Inc. is seeking a highly capable Validation Engineer to support validation activities for Blow-Fill-Seal (BFS) equipment, with additional scope across compounding and packaging systems.

You will be working within a dynamic CDMO environment specializing in ophthalmic, inhalation, and irrigation products, helping to ensure all systems meet current Good Manufacturing Practices (cGMP), FDA, and client quality expectations.

Key Responsibilities:

• Lead and execute validation lifecycle documentation (URS, IQ, OQ, PQ) for Blow-Fill-Seal equipment used in sterile liquid product manufacturing.
• Support validation of compounding systems, including mixers, tanks, and associated CIP/SIP systems.
• Perform packaging line validation for sterile fill finish operations.
• Collaborate with cross-functional teams (QA, Engineering, Operations) to execute validation deliverables according to project timelines.
• Write and manage change controls, deviations, and CAPAs related to validation activities.
• Ensure all validation work aligns with internal SOPs, regulatory expectations, and customer-specific requirements.
• Assist in audit readiness activities and represent the validation function during inspections or client visits.
• Contribute to continuous improvement initiatives by identifying gaps and optimizing validation practices.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related technical field.
• Minimum 4 years of experience in pharmaceutical or medical device manufacturing.
• 4+ years of direct validation experience, including hands-on protocol generation and execution.

Preferred Qualifications:

• Strong understanding of BFS technology, sterile processes, and related regulatory standards (21 CFR Part 11, EU Annex 1, etc.).
• Experience in CDMO environments and third-party client interactions is preferred.
• Familiarity with ASTM E2500, GAMP 5, and risk-based validation approaches.

POSITION SUMMARY

The Controls Leader will provide key leadership with regard to power and control systems, equipment specification and maintenance, proper operation, technician development, troubleshooting and repair to achieve or exceed reliability targets the plant. This role has responsibility for systems optimization, compliance, personnel safety and technician skill development relative to plant electrical power and process control systems.

KEY RESPONSIBILITIES

• Assists primary administrator and troubleshooter for plant power and control systems and is a key member of plant technical leadership.
• Provides input to the Engineering Projects Manager to develop and manage power and control standards and ensure application of the standards on all projects and upgrades.
• Leads the execution of the site masterplan for power and controls systems to include understanding of the installed base, and replacement plan for obsolete equipment/technologies.
• Builds and maintains a sustainable system for plant Electrical & Instrumentation (E&I) technicians skill development. Coaches technicians on skill assessment and development of operating within the department.
• Manages Electrical & Instrumentation (E&I) technicians and daily direction setting.
• Knows, communicates, and ensures technician compliance to local and national regulator codes (NFPA 70, NFPA 70e, NFPA 79 and OSHA 1910). Is also responsible for ensuring equipment and safe practice compliance in their area of responsibility.
• Responsible for validation of the MES data from PLCs. Support plant Process Engineers in conditioning PLC data to accommodate effective data analysis including application development.
• Provides support in the design and implementation of machine control and process automation applications, such as: control strategies, HMI design, MES applications and KPI development.
• Works with engineering and operations to identify losses, and develop plans and strategies to eliminate them, in the areas of safety, quality, reliability and cost.
• Owns parts or whole Key Elements for systems related to power and control system such as electrical safety (LOTO, Electrical PPE, Energized work permits, low voltage qualification, etc.) and Quality/CCP compliance (checkweighers, metal detectors, vision systems, ingredient flows, temperatures, etc.).
• Works closely with engineering and operations leaders on selection and installation/start-up of new equipment. Becomes the technical expert on new equipment and ensures the training of others regarding control systems.
• Provides power and controls engineering support on capital initiatives.
• Provides support throughout other parts of the plant as needed on a daily basis.
• Learns and applies control, simulation and process modeling technologies to analyze and improve overall process and packaging operations.

Education

• Bachelor's Degree in Engineering is required; Electrical engineering degree is preferred

Experience

• 5 years of relevant controls experience is required
• Manufacturing experience is preferred
• Mechanical and electrical experience in food manufacturing is preferred

Other

• Ability to work and manage within a team environment
• Strong knowledge of machine and/or process control hardware, instrumentation and software including Allen Bradley PLC and Rockwell FactoryTalk platforms
• Working knowledge of NFPA and OSHA guidelines related to electrical equipment and practices
• Proficiency in plant historian
• Understanding of technical systems and terminology
• Experience learning and integrating new technologies
• Experience leading the installation of equipment in food manufacturing environment
• Demonstrated results in manufacturing maintenance utilizing maintenance systems
• Experience with plant systems software
• Self-motivated and able to motivate others
• Strong organizational, critical thinking, and problem-solving skills
• Effective presentation, verbal, and written communication skills
• Proficient in Microsoft Suite applications
• Excellent interpersonal skills
• Willingness to work off-shifts or weekends as needed, as well as to take off-shift support calls as needed
• Experience leading, teaching or managing others effectively
• Some travel required
• Able to perform moderate activity including but not limited to, significant time spent on manufacturing floor and some physical work on equipment

• Process Development & Optimization: Design and refine manufacturing processes to maximize uptime, minimize waste, and meet customer specifications while considering material properties, equipment capabilities, and operator workflows
• Continuous Improvement: Lead Lean and Six Sigma initiatives to drive efficiency and enhance product quality; propose and execute projects using PDCA methodology with clear ROI justification
• Troubleshooting & Problem Solving: Conduct root cause analysis using tools such as Ishikawa diagrams, 5 Whys, and Pareto Analysis; develop corrective actions including A3, 8D, and Supplier Corrective Action Reports (SCAR)
• Data Analysis & Reporting: Analyze process data to identify trends and improvement opportunities; establish data collection methods, train operators, and deliver KPI reports (daily, weekly, monthly, quarterly) to support strategic decisions
  
  

• Bachelor's degree in Mechanical, Industrial, Manufacturing Engineering, or related field
• 5+ years of experience in process engineering, manufacturing optimization, or continuous improvement roles
• Strong knowledge of Lean Manufacturing and Six Sigma methodologies
• Automotive industry experience preferred
• Familiarity with Core Tools (APQP, PPAP, FMEA, SPC, MSA) is a plus
  
  

About the Role

Brent Scarbrough & Company is seeking a Construction Scheduling Engineer to lead and execute planning and scheduling functions across a diverse portfolio of construction projects. This role is ideal for a detail‑oriented, proactive professional who thrives in fast‑moving environments and collaborates well with teams at all levels.

You’ll play a critical role in ensuring projects stay on track, resources are effectively coordinated, and schedules reflect real‑time project needs—all while fostering a culture of teamwork, safety, and continuous improvement.

What You’ll Do

• Lead construction scheduling activities for both estimating pursuits and active projects
• Develop, maintain, and monitor project schedules to ensure accurate sequencing and timely delivery
• Implement scheduling standards and ensure project compliance
• Coach and mentor BSC teammates regarding CPM scheduling techniques and Best Practices
• Support estimators and field leaders with schedule insight and resource coordination
• Promote and support BSC Safety Program
• Collaborate with customers, architects, subcontractors, and other project stakeholders in optimizing project schedules
• Improve site logistics workflows and offer process‑enhancing solutions
• Partner cross‑functionally to support project execution
• Handle additional responsibilities as needed

What We’re Looking For

• Bachelor’s degree in construction management, Engineering, or related field
• 3+ years of construction experience (or equivalent experience/training)
• Experience as a Project Engineer is a plus
• Expert-level knowledge of common CPM scheduling software tools such as: Oracle Primavera P6; Microsoft Project; and ASTA Powerproject
• Strong written and verbal communication skills
• Active listener who values diverse input and constructive feedback
• Willingness to travel based on project needs
• Deep understanding of scheduling concepts, tools, and construction sequencing
• Proficiency in schedule review, interpretation of plans/specifications, and 4D visual planning
• Familiarity with project management fundamentals, contracts, buyout, and cost/resource‑loaded schedules
• Analytical, innovative problem‑solver able to handle complex project challenges
• Team‑oriented, collaborative, and organized
• Results‑driven with a commitment to accuracy and timeliness

Why Join Us?

You’ll have the opportunity to influence project outcomes, shape team development, and contribute to the successful delivery of major construction projects—while working in a supportive, growth‑minded environment.

Call Notes from Hiring manager

15+ years of experience

Routing — BGP, EIGRP — MUST HAVE

Firewall— new network, migration from Cisco ASA to Cisco Secure Firewall — Customers today migrate from Cisco ASA to:

Cisco Secure Firewall Threat Defense (FTD) — MUST HAVE

This is Cisco’s official and recommended upgrade path, supported by automated migration tools.

CISCO certifications is a plus

Key Responsibilities

Design, develop, install, and maintain enterprise network infrastructure, including routers, switches, and related equipment

Implement and manage network security solutions, including firewalls, ACLs, and object groups

Monitor network performance and proactively troubleshoot outages or performance issues

Perform routine network maintenance, including firmware and software upgrades

Provide remote and on-site technical support to internal teams and business users

Test, deploy, and support new network hardware, software, and applications

Develop detailed engineering design packages to integrate new technologies into existing environments

Collaborate with clients, vendors, and cross-functional technical teams to ensure network reliability and quality

Create strategic roadmaps for future hardware and software upgrades and enhancements

Participate in network audits, quality reviews, and standards compliance initiatives

Follow disciplined change management practices with awareness of downtime impact in industrial environments

Perform additional duties as required

Minimum Qualifications

Bachelor’s degree in Computer Science, Information Technology, or equivalent IT/OT discipline from an accredited institution

15+ years of network engineering or related experience, preferably in an industrial or large-scale enterprise environment

Active Cisco CCNP certification preferred (or Siemens CPIN-level equivalent)

Proven ability to work independently with minimal supervision

Strong analytical, problem-solving, and troubleshooting skills

Excellent verbal and written communication skills

Ability to manage multiple tasks with strong attention to detail

Demonstrated ability to learn and adopt new technologies quickly

Job Summary: CS Sunshine Holdings is looking for a Lean Engineer to implement and drive lean manufacturing initiatives across our U.S. manufacturing facilities. The role will emphasize shop-floor engagement, building operational capabilities, and sustaining continuous improvement across production and support teams. This role partners closely with Operations, Engineering, Quality, EHS, and Supply Chain teams to identify waste, improve flow, stabilize processes, and embed a Lean culture within the organization.

Responsibilities include:

• Act as a hands-on Lean practitioner on the production floor, supporting daily operations and continuous improvement activities.
• Coach operators, supervisors, and engineers on Lean fundamentals, problem-solving methods, and standard work.
• Lead and facilitate Kaizen events, Gemba walks, and value stream mapping activities.
• Identify waste and process gaps in safety, quality, delivery, cost, and morale (SQDCM), and drive countermeasures.
• Develop, implement, and sustain standard work, visual management, and 5S systems.
• Support line balancing, cycle time analysis, takt time alignment, and material flow optimization.
• Apply structured problem-solving tools (A3, PDCA, 5-Why, Fishbone) to address chronic issues.
• Partner with Industrial Engineering and Operations teams to improve OEE, yield, labor productivity, and changeover performance.
• Track and report Lean KPIs and improvement results; support weekly/monthly operational reviews.
• Support new line ramp-up, process stabilization, and continuous improvement during build and expansion phases.
• Serve as a change agent, reinforcing Lean mindset, discipline, and accountability across teams.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in industrial engineering, Manufacturing Engineering, Operations Management, or related field.
• 2+ years of hands-on experience in manufacturing or operations-focused continuous improvement roles.
• Practical experience applying Lean tools in a production or warehouse environment (not only theoretical knowledge).
• Strong understanding of Lean principles, including standard work, pull systems, flow, and waste elimination.
• Experience with time studies, work measurement, line balancing, and basic OEE analysis.
• Ability to coach and influence front-line teams through data, observation, and clear communication.
• Proficient in Excel; familiarity with basic data analysis and visualization is preferred.
• Comfortable working in fast-paced, build-phase, or ramp-up manufacturing environments.

Preferred Qualifications:

• Lean certification (Lean Practitioner, Lean Coach, Green Belt, or equivalent).
• Experience supporting high-volume or automated production lines.
• Exposure to training delivery or coaching roles within manufacturing.
• Familiarity with safety, quality, and production management systems.

Physical Requirements and Working Conditions

• Frequent presence on the production floor, including standing, walking, bending, and observing operations.
• Occasional sitting for analysis, documentation, and reporting work.
• Ability to lift light materials (up to 10–15 lbs) as needed.
• Visual and auditory ability to observe processes, read displays, and communicate effectively in manufacturing environments.
• Ability to work in areas with typical factory noise levels and PPE requirements.
• Ability to attend meetings and interact with employees, clients, and vendors

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.