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Product Design Engineer

Location: Chicago – Ravenswood Area

Type: Long-Term Contract (1+ Year)

Pay Rate: $38–$48/hour

Are you a detail-driven Product Design Engineer who enjoys refining and improving real-world products? This is an exciting long-term contract opportunity to work on high-impact mechanical products in a regulated environment—where precision, documentation, and thoughtful design updates truly matter.

This role is ideal for an engineer who thrives on modifying and enhancing existing designs based on testing and validation feedback rather than early-stage concept development. You’ll play a key role in strengthening product performance, reliability, and compliance.

What You’ll Do

• Modify and improve existing mechanical designs using SolidWorks
• Update engineering drawings, revisions, and controlled documentation
• Apply Design Control principles throughout the product lifecycle
• Support product updates driven by testing, validation, and prototyping results
• Work with mechanical assemblies featuring moving parts such as springs, collapsible mechanisms, and precision components
• Ensure compliance within a regulated industry environment

What We’re Looking For

• 3+ years of mechanical/product design experience
• Strong proficiency in SolidWorks (this is a must-have)
• Experience designing plastic parts and mechanical assemblies
• Solid understanding of engineering drawings and revision control
• Working knowledge of Design Controls
• Medical device experience and ISO 13485 familiarity preferred
• Experience in other regulated industries (aerospace, defense, etc.) is also highly valued

Why This Opportunity Stands Out

• Long-term, stable contract assignment (1+ year)
• Competitive hourly compensation
• Full employee benefits package including:
• Paid time off and paid holidays
• Three medical plan options
• Dental and vision coverage
• 401(k)
• Employee Stock Ownership (ESOP) plan

If you’re a hands-on mechanical engineer who enjoys improving complex products in a structured, quality-driven environment, this role offers the stability, technical challenge, and professional growth you’re looking for—right in the Ravenswood area of Chicago.

Job Title: Systems Engineer

Location: Oro Valley, AZ (Onsite)

Duration: 18-Month Contract

About the Role

Seeking a motivated, hands-on Systems Engineer to support a new Project, focused on advancing cancer diagnostics through state-of-the-art testing automation. This role plays a critical part in defining product requirements, system architectures, and risk management strategies for in-vitro diagnostic (IVD) solutions used globally across more than 250 cancer tests and associated instruments.

This is an onsite position ideal for an engineer with strong electro-mechanical systems experience and a background in regulated medical device development.

Key Responsibilities

• Apply Systems Engineering principles across the product lifecycle, including requirements definition, system architecture, risk analysis, and verification & validation
• Manage front-end systems engineering deliverables related to requirements, risks, trade studies, and testing
• Plan and execute requirements management, risk analysis, and V&V activities
• Analyze complex technical problems, develop solution options, and support data-driven decision-making
• Conduct industry and technology assessments, including emerging trends and competitive product analysis
• Collaborate cross-functionally with R&D, Marketing, Operations, Quality, and Regulatory teams
• Engage with business stakeholders and Voice-of-Customer (VoC) representatives to align technical solutions with customer needs

Required Qualifications

• Experience in front-end Systems Engineering, including requirements engineering, architecture definition, risk management, and trade-off analysis
• Hands-on experience with systems and hardware integration and testing
• Experience working in a regulated medical device environment
• Familiarity with FDA, ISO, and other applicable diagnostic product standards
• Experience using systems engineering tools such as RETINA or similar platforms

Preferred Qualifications

• Deep knowledge of reliability, manufacturability, and usability engineering
• Strong leadership presence with the ability to build authority and accountability within cross-functional teams
• Excellent communication, collaboration, and stakeholder-management skills
• Strong organizational skills with the ability to prioritize and manage multiple workstreams effectively

#Verification #Validation #RETINA #Diagnostics #pharma #pharmaceutical #lifescience #medicaldevice #IBMDOORS OR #DOORSNext #JamaConnect #Polarion #WindchillRV&S #PTCIntegrity #HPALM #QualityCenter #INCOSE #requirementsengineering #requirementsgathering #requirementsmanagement

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging.

We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives.

Position Title: Chemistry Lab Technician

Location: Onsite at Canyon Labs in Rush, New York

Schedule: Monday – Friday 8:00AM – 5:00PM

Hourly Pay Range: $25.00 - $28.00

Chemistry Lab Technician Job Summary:

We are seeking a highly motivated Chemistry Lab Technician to join our Analytical Chemistry team. The ideal candidate will have hands-on experience with analysis using Gas Chromatography with Flame Ionization Detection (GC-FID), and High-Performance Liquid Chromatography (HPLC). This role involves preparing samples for analysis, performing analytical testing while ensuring accurate and reliable results, maintaining instrumentation, and ensuring compliance with regulatory standards.

Chemistry Lab Technician Key Responsibilities:

• Prepare, extract, and analyze samples for various analytical workflows including chromatography assays, physiochemical analyses, and traditional wet chemistry analyses.
• Support extractables and leachables (E&L) studies following approved protocols and compendial guidance.
• Operate and maintain analytical instrumentation including HPLC, GC, and associated detectors (e.g., UV, FID, MS as applicable).
• Perform routine sample preparation (weighing, dilution, filtration, solvent extraction) with strong attention to trace-level contamination control.
• Conduct analysis for water and medical device testing.
• Prepare and analyze samples according to SOPs, WIs and industry guidelines.
• Maintain accurate and detailed laboratory records, logbooks, lab notebooks, and study documentation.
• Adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) where applicable.
• Support method development and validation for new analytical procedures.
• Ensure compliance with FDA, USP, ISO, ICH, and other regulatory guidelines.

Chemistry Lab Technician Qualifications & Skills:

• Education: Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related field.
• Experience:
• Proficiency in GC-MS/FID and HPLC-UV-MS analysis (MS preferred but not required).
• Familiarity with sample preparation techniques and data interpretation.
• Knowledge of GLP/GMP regulations and laboratory best practices.
• Strong problem-solving skills and attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong organizational and communication skills.

Chemistry Lab Technician Preferred Qualifications:

• Prior experience in a pharmaceutical, environmental, or industrial analytical lab.
• Experience with chromatography instrument software for GC-FID, TOC, and ICP-MS.
• Understanding of method validation, USP/NF, and ICH guidelines.

Canyon Labs offers several benefits as part of your total compensation, including but not limited to:

• Paid Time Off, Sick Time, and Paid Holidays
• Medical, Dental and Vision Insurance
• Long term disability insurance, life insurance
• 401(k) with company match up to 4%

At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging.

We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives.

Position Title: Biocompatibility & Toxicology Technician

Location: Onsite at Canyon Labs in West Henrietta, New York

Schedule: Monday – Friday 8:00AM – 5:00PM

Overtime: Occasionally Required

Hourly Pay Range: $22.00 - $30.00

Biocompatibility & Toxicology Technician Job Overview

We are seeking a dedicated and detail-oriented Technician to join our dynamic team. The ideal candidate will play a crucial role in supporting in vivo pre-clinical testing work for our customers developing pharmaceuticals and medical devices utilizing small laboratory animals. This position involves working in a fast-paced environment where you will contribute to various projects related to safety and effectiveness. The Technician will utilize their expertise in laboratory techniques and adhere to Good Laboratory Practice (GLP) standards to ensure the integrity of study outcomes.

Biocompatibility & Toxicology Job Duties

· Conduct experiments and assist in safety studies, ensuring compliance with established protocols.

· Conduct In vivo GLP/GMP/Research Medical Device biocompatibility testing

· Assist with in vivo study method development

· Responsible for procedures such as health monitoring, observations, test article administration, weighing, identification, blood and tissue collection, extract preparation and animal handling

· Assist with in vitro GLP and non-GLP studies (i.e. cytotoxicity)

· Prepare and release protocols, reports, data sheets, SOPs and notebooks

· Participate in committees as assigned by management

· Collaborate with cross-functional teams to facilitate the flow of information and data throughout the testing process.

· Document procedures, results, and maintain accurate records in accordance with regulatory requirements .

· Assist in the preparation of materials for safety studies, including reagents and samples.

· Maintain a clean and organized research laboratory environment, adhering to safety protocols.

Biocompatibility & Toxicology Technician Job Requirements

· Bachelor’s degree in a relevant field such as biology, vet technology, or life sciences preferred.

· Experience in pre-clinical testing or a research laboratory setting is highly desirable.

· Proficiency in techniques such as animal handling, substance administration and blood collection preferred.

· Strong understanding of pre-clinical safety testing processes including ISO-10993, and Good Laboratory Practice (GLP) guidelines.

· Excellent organizational skills with attention to detail and the ability to manage multiple tasks effectively.

· Strong communication skills, both written and verbal, to collaborate with team members effectively.

· Ability to work independently as well as part of a team in a fast-paced environment.

Canyon Labs offers several benefits as part of your total compensation, including but not limited to:

• Paid Time Off, Sick Time, and Paid Holidays
• Medical, Dental and Vision Insurance
• Long term disability insurance, life insurance
• 401(k) with company match up to 4%

At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.

Duration: 6 months contract, Full-Time

Employment Type: W-2

Job Description:

• This role focuses on designing, developing, and supporting FPGA-based solutions for advanced robotic and medical systems. The engineer will own RTL design from architecture through validation, working hands-on across the full FPGA development lifecycle, including simulation, timing closure, hardware bring-up, and system-level debugging.
• The position requires close collaboration with hardware, firmware, software, and systems teams in a highly cross-functional, regulated R&D environment to deliver reliable, safety-critical technology.

Responsibilities:

Key responsibilities include, but are not limited to:

• Designing, developing, optimizing, and maintaining FPGA RTL using Verilog/SystemVerilog and/or VHDL
• Suporting the full FPGA development lifecycle, including synthesis, place-and-route, timing closure, and bitstream generation
• Performing functional simulation, verification, and system-level debugging.
• Supporting board bring-up, testing, integration, and validation.
• Collaborating closely with hardware, firmware, software, and systems engineering teams.
• Documenting design decisions, test results, and process improvements.
• Participating in design reviews and regulated development activities.

Experience:

• 4+ years of hands-on FPGA design and development experience.
• Strong understanding of digital logic, timing analysis, and debugging.
• Proficiency in Verilog/SystemVerilog.
• Experience with FPGA toolchains such as Xilinx Vivado, Lattice Diamond, or equivalent.
• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related scientific field.
• Robotics design exposure.
• Strong collaboration and communication skill.

Skills:

Preferred Skills and Experiece:

• Prior experience in medical devices, robotics, or safety-critical systems
• Exposure to regulated environments such as FDA, IEC, or ISO
• End-to-end FPGA ownership from architecture through validation
• Experience debugging real hardware issues beyond simulation
• Familiarity with high-speed protocols such as PCIe, Ethernet, DDR, or Aurora
• Experience using simulation, verification, and hardware debug tools (logic analyzers, oscilloscopes)
• Cross-functional collaboration with mechanical, systems, or clinical teams

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: I.Prudvi kumar

Email:

Internal Id: 26-04157

Role: Senior Security Analyst

Location: Onsite, Addison TX (no relocation)

Duration: 4 months, Contract-to-Hire

Pay rate: W2 Only, NO Third Party

Overview:

As a Sr. Security Analyst, you will play a critical role in guiding the day-to-day and strategic direction of the company's IT security and compliance initiatives. You will help shape and implement our security posture, support regulatory compliance efforts (HIPAA, SOC 2), and serve as a trusted advisor across both technical and non-technical teams. You will also provide mentorship to junior analysts, drive cross-functional security projects, and begin to take on leadership responsibilities as the company prepares to scale its security function into a full management structure.

Requirements:

• Bachelor’s degree in information security, Computer Science, or related field—or equivalent professional experience.
• 5+ years of experience in information security roles, ideally in healthcare or regulated environments.
• 5+ years of general IT experience across systems, networking, or cloud platforms.
• Deep expertise in Microsoft 365 & Azure, including Defender, Sentinel, and Purview.
• Proven experience with security frameworks such as NIST CSF, HITRUST, or ISO 27001.
• Hands-on knowledge of security platforms and practices (SIEM, vulnerability management, IDS/IPS, MDR/EDR).
• Familiarity with compliance frameworks including HIPAA and SOC 2.

Please send resume ASAP.

We are seeking an experienced Contract Project Manager to lead the design, construction, validation, and operational readiness of a new 503B Outsourcing Facility in Charleston, SC. This project involves the build-out of a modular cleanroom pharmaceutical manufacturing area, within an existing structure, to be compliant with U.S. FDA 503B regulations and current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211.

The Project Manager will oversee the full lifecycle of the facility build, including planning, vendor coordination, cleanroom installation, utilities integration, validation, regulatory readiness, and handoff to operations.

Key Responsibilities

Project Leadership & Execution

• Lead end-to-end execution of a modular cleanroom manufacturing and supporting structure area build.
• Develop and manage detailed project plans, budgets, schedules, and milestones.
• Coordinate cross-functional stakeholders including Engineering, Quality, Regulatory, Validation, Manufacturing, and Executive Leadership.
• Serve as the primary point of contact for contractors, cleanroom vendors, equipment suppliers, and consultants.
• Proactively identify risks and implement mitigation strategies to maintain timeline and budget.

Facility Design & Construction Oversight

• Oversee modular cleanroom design, fabrication, delivery, and installation.
• Ensure facility layout supports compliant workflows, material/personnel flows, and environmental controls.
• Coordinate mechanical, electrical, plumbing (MEP), HVAC, HEPA filtration, and critical utility systems (WFI, clean steam, compressed gases, etc.).
• Manage general contractors and subcontractors to ensure compliance with project specifications and cGMP requirements.

Regulatory & Compliance Alignment

• Ensure facility design and build align with Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable FDA guidance.
• Support readiness for FDA inspection and state Board of Pharmacy requirements.
• Collaborate with Quality and Validation teams to ensure proper documentation (URS, FS, DS, IQ/OQ/PQ protocols).
• Ensure adherence to cGMP standards and applicable USP chapters (e.g., USP , ).

Validation & Commissioning

• Oversee commissioning and qualification activities for cleanrooms and critical systems.
• Coordinate environmental monitoring setup and validation activities.
• Support process simulation activities for sterility assurance.
• Support development of SOPs related to facilities and equipment.
• Ensure successful facility turnover to Manufacturing and Quality teams.

Budget & Reporting

• Manage capital expenditure budget and vendor contracts.
• Track project performance metrics and provide regular executive-level updates.
• Ensure change control processes are followed for scope, schedule, and budget modifications.

Required Qualifications

• 7+ years of project management experience in pharmaceutical, biotech, or sterile compounding environments.
• Demonstrated experience leading construction or expansion of GMP-regulated manufacturing facilities.
• Direct experience with cleanroom builds (ISO 7/8 and higher classification preferred).
• Strong knowledge of FDA cGMP regulations and 503B outsourcing facility requirements.
• Experience managing modular construction projects preferred.
• Advanced proficiency with MS Project and/or other project management software.
• Proven ability to manage multi-vendor, cross-functional projects with aggressive timelines.
• Bachelor’s degree in Engineering, Construction Management, Life Sciences, or related field (PMP certification preferred).

Preferred Experience

• Prior experience building or remediating a 503B outsourcing facility.
• Experience preparing facilities for FDA inspection.
• Familiarity with Charleston, SC permitting and construction environment.
• Background in sterile injectable manufacturing.

Key Competencies

• Strong leadership and stakeholder management skills
• Excellent organizational and documentation practices
• Risk-based decision-making approach
• Detail-oriented with strong compliance mindset
• Ability to work on-site in Charleston, SC for critical phases

Deliverables

• Completed modular cleanroom facility delivered on time and within budget
• Fully commissioned and qualified GMP-compliant facility
• Inspection-ready documentation package
• Successful transition to operational manufacturing

This contract role offers a unique opportunity to lead the build of a state-of-the-art 503B modular pharmaceutical manufacturing facility from the ground up within an existing building. The ideal candidate thrives in complex, regulated environments and brings both construction execution expertise and deep GMP knowledge.

To apply, please submit your resume and a brief cover letter describing your relevant

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