Manufacturing Engineer jobs at Venteon

Essential Duties and Responsibilities: Mentors, coaches, and teaches Manufacturing technicians to perform routine AVI activities for syringes and cartridges as well as support pen packaging and pen assembly activities. Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements. Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements. Actively participate in new equipment and process qualifications. Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization by using effective project management, cost control techniques, and Lean Manufacturing. Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing. Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis. Minimum Qualifications (Knowledge, Skills, and Abilities) Minimum Qualifications (Knowledge, Skills, and Abilities) Bachelor's degree with 8+ years demonstrated ability in a cGMP production environment. Associate degree and 10 years of cGMP production experience or High School degree with 12 years of experience of cGMP production experience may be considered. Experience in automated visual inspection and/or packaging. 2+ years of supervisory experience. Ability to manage teams to execute activities on the manufacturing floor. Experience in a data-driven approach to root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma, 5-why, fishbone diagram). Ability to adapt to changing priorities as project demands and business needs change. Demonstrated excellence in oral and written communication. Preferred Qualifications: Experience with equipment qualification. Lean Manufacturing/Six Sigma Green Belt Certification preferred. Experience and greenfield facility start-up experience preferred. Ability to explain complex technical issues to external customers/agencies.

Position involves support of senior staff in the initiation, design, and delivery of manufacturing projects, particularly for facilities-related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for facilities system, perform quality and overall facilities walkdowns. Perform field evaluations of existing systems and provide engineering design recommendations. Responsibilities Provide support to Facilities Senior Manager on various ongoing activities, including new projects Accountable for walkdowns and punch list resolution Daily responsibilities will vary based on the need of the business; it can be from maintenance operation to punch lists resolution. Required Skills self-starter Ability to communicate effectively Ability to manage tasks to completion Experience with facilities management and projects in a biotech/pharmaceutical manufacturing environment is a must Preferred Skills Masters degree OR Bachelors degree and 2 years of experience OR Associates degree and 6 years of experience OR High school diploma / GED and 8 years of experience

We are seeking an experienced and dynamic Manufacturing Manager to oversee daily operations within our manufacturing facility. The ideal candidate will lead production teams, ensure quality standards, and optimize manufacturing processes to meet company goals. This leadership role requires strategic planning, excellent communication skills, and a strong understanding of manufacturing systems. The Manufacturing Manager will play a key role in driving efficiency, safety, and continuous improvement across all production activities. Direct hire, Located in Placentia, CA 92870 Offering $110K-130K DOE Duties Monitor all manufacturing operations and processes to ensure compliance to ISO 9001 and safety standards. Analyze operating reports and plan for annual budgets to support business needs that help to meet or exceed company targets and goals. Maintain a safe work environment and follow all safety regulations Oversee daily floor manufacturing operations, while mentoring manufacturing Supervisors and Process Engineer to support you with daily task and activities. Use Strategy Deployment to develop and create a continuous improvement mind set with a focus on safety, first pass reliability, decreasing scrap, and increasing efficiency. Support manufacturing departments to help with inventory management, equipment maintenance, and material management in the plant. Support the quality department to establish best in class quality and establish standard processes and training for all plant personal. Analyze operating expenses and look for ways to reduce costs in our production and labor cost. Responsible for ensuring conflicts are managed and resolved among departments and employees. Responsible for hiring and training new employees along with performance managing employees to meet company standards. Support the maintenance department activities to help reduce downtime on machines and keep the facility in excellent working condition. Ensure all legal requirements, company safety procedures, and local and state health and safety regulations are met. Maintain a safe work environment through training, equipment, and process improvements. Develop and communicate productivity and efficiency goals and plans to meet those goals Establish cost control programs to meet or beat budgeted/forecasted levels in staffing and manufacturing expenses. Responsible for continuous improvement in manufacturing operations to ensure quality products - minimize defects and control waste and scrap. Establish and achieve scrap/material usage variance goals. Develop and implement programs to reduce material costs through better production methods in Compounding, Casting, Coating, and Converting. Experience Bachelor's Degree in an engineering discipline or related field. 5 years' experience in a manufacturing organization. 3 years' experience in a supervisory/management experience. Understanding of a processing related environment (example: coating, roll to roll printing and extrusion concepts). Demonstrate strong leadership, team building and advanced coaching skills. Experienced in talent development ability to motivate people, assess, and develop employee skills. Demonstrated understanding of the principles and applications associated with manufacturing operations, maintenance and engineering. Excellent planning and organizational skills, with the ability to balance production and maintenance needs. Excellent interpersonal communication and listening ability. SAP experience Six Sigma, Lean Certifications a plus. Must demonstrate strong critical thinking and problem-solving skills. Excellent communication skills required (interpersonal, verbal, written, listening, presentation). Must have the ability to communicate effectively with all levels of organization and external suppliers and customers. Basic to advanced computer skills in MS Office Positive outlook, professional demeanor, with a strong work ethic, that includes attendance, organization, accuracy, attention to detail, good judgement, and discretion. Personally guided by, espouses, communicates, works with, and through, values of integrity, excellence, inspirational, teamwork and accountability

As a Site Reliability Engineer (Contractor), you will be a hands-on contributor, focused on supporting and improving the reliability of our AWS cloud infrastructure. You will apply core SRE principles to automate operational tasks, monitor system health, and participate in incident response. This role is execution-focused, supporting the senior team in ensuring our services are available and performant while maintaining an awareness of healthcare compliance standards. The contract extension beyond 3 months will be on the need basis. Key Responsibilities (Contract Deliverables) Cloud Infrastructure Execution & Maintenance: Assist in deploying, configuring, and maintaining highly available AWS infrastructure components. Execute Infrastructure as Code (IaC) changes using tools like Terraform to provision and configure resources. Support the operations and maintenance of existing containerized applications running on platforms like Kubernetes and Docker. AWS Networking Support: Assist the senior team in maintaining the security and efficiency of our core AWS network topologies (e.g., VPCs, subnets, routing). Perform basic configuration and maintenance of cloud load balancing (ALB/NLB) and DNS services (Route 53). Support the enforcement of network security policies and assist in routine network troubleshooting for connectivity or latency issues. Site Reliability & Automation: Identify and automate routine manual operational tasks using scripting (Python/Bash) to improve efficiency and reduce toil. Participate in blameless post-mortems and incident response efforts, focusing on documenting steps taken and assisting with root cause analysis. Contribute to the documentation and adherence of established Service Level Objectives (SLOs) and Service Level Indicators (SLIs). Monitoring & Compliance: Maintain and use existing monitoring, logging, and alerting systems (e.g., Prometheus, Grafana, ELK stack) to ensure system health. Assist in managing and verifying CI/CD pipelines to ensure safe and efficient software releases. Support compliance efforts by ensuring operational procedures align with security best practices and regulatory requirements (HIPAA, SOC 2). Required Qualifications 8+ years of hands-on experience in a DevOps, Cloud Engineering, or SRE-focused technical role. Solid practical experience with AWS cloud provider services. Hands-on experience with Linux administration and troubleshooting. Proficiency in scripting languages such as Python, Bash, etc for automation. Solid experience with Infrastructure as Code tools such as Terraform. Experience with containerization technologies such as Docker and Kubernetes. Experience with monitoring systems like Prometheus, Grafana, AWS Cloud Watch. Experience with writing SQLs on PostgreSQL DB. Working understanding of core networking principles (VPC, routing, load balancing). Basic understanding of security and compliance requirements in a regulated industry (e.g., healthcare, finance). Preferred Qualifications Relevant certifications such as AWS Certified SysOps Administrator or AWS Certified Developer. Familiarity with CI/CD tools (e.g., Jenkins, GitLab CI). Compensation: $72 - $90 per hour ID#: 2508

As a Site Reliability Engineer (Contractor), you will be a hands-on contributor, focused on supporting and improving the reliability of our AWS cloud infrastructure. You will apply core SRE principles to automate operational tasks, monitor system health, and participate in incident response. This role is execution-focused, supporting the senior team in ensuring our services are available and performant while maintaining an awareness of healthcare compliance standards. The contract extension beyond 3 months will be on the need basis. Key Responsibilities (Contract Deliverables) Cloud Infrastructure Execution & Maintenance: Assist in deploying, configuring, and maintaining highly available AWS infrastructure components. Execute Infrastructure as Code (IaC) changes using tools like Terraform to provision and configure resources. Support the operations and maintenance of existing containerized applications running on platforms like Kubernetes and Docker. AWS Networking Support: Assist the senior team in maintaining the security and efficiency of our core AWS network topologies (e.g., VPCs, subnets, routing). Perform basic configuration and maintenance of cloud load balancing (ALB/NLB) and DNS services (Route 53). Support the enforcement of network security policies and assist in routine network troubleshooting for connectivity or latency issues. Site Reliability & Automation: Identify and automate routine manual operational tasks using scripting (Python/Bash) to improve efficiency and reduce toil. Participate in blameless post-mortems and incident response efforts, focusing on documenting steps taken and assisting with root cause analysis. Contribute to the documentation and adherence of established Service Level Objectives (SLOs) and Service Level Indicators (SLIs). Monitoring & Compliance: Maintain and use existing monitoring, logging, and alerting systems (e.g., Prometheus, Grafana, ELK stack) to ensure system health. Assist in managing and verifying CI/CD pipelines to ensure safe and efficient software releases. Support compliance efforts by ensuring operational procedures align with security best practices and regulatory requirements (HIPAA, SOC 2). Required Qualifications 8+ years of hands-on experience in a DevOps, Cloud Engineering, or SRE-focused technical role. Solid practical experience with AWS cloud provider services. Hands-on experience with Linux administration and troubleshooting. Proficiency in scripting languages such as Python, Bash, etc for automation. Solid experience with Infrastructure as Code tools such as Terraform. Experience with containerization technologies such as Docker and Kubernetes. Experience with monitoring systems like Prometheus, Grafana, AWS Cloud Watch. Experience with writing SQLs on PostgreSQL DB. Working understanding of core networking principles (VPC, routing, load balancing). Basic understanding of security and compliance requirements in a regulated industry (e.g., healthcare, finance). Preferred Qualifications Relevant certifications such as AWS Certified SysOps Administrator or AWS Certified Developer. Familiarity with CI/CD tools (e.g., Jenkins, GitLab CI). Compensation: $72 - $90 per hour ID#: 2508

As a Site Reliability Engineer (Contractor), you will be a hands-on contributor, focused on supporting and improving the reliability of our AWS cloud infrastructure. You will apply core SRE principles to automate operational tasks, monitor system health, and participate in incident response. This role is execution-focused, supporting the senior team in ensuring our services are available and performant while maintaining an awareness of healthcare compliance standards. The contract extension beyond 3 months will be on the need basis. Key Responsibilities (Contract Deliverables) Cloud Infrastructure Execution & Maintenance: Assist in deploying, configuring, and maintaining highly available AWS infrastructure components. Execute Infrastructure as Code (IaC) changes using tools like Terraform to provision and configure resources. Support the operations and maintenance of existing containerized applications running on platforms like Kubernetes and Docker. AWS Networking Support: Assist the senior team in maintaining the security and efficiency of our core AWS network topologies (e.g., VPCs, subnets, routing). Perform basic configuration and maintenance of cloud load balancing (ALB/NLB) and DNS services (Route 53). Support the enforcement of network security policies and assist in routine network troubleshooting for connectivity or latency issues. Site Reliability & Automation: Identify and automate routine manual operational tasks using scripting (Python/Bash) to improve efficiency and reduce toil. Participate in blameless post-mortems and incident response efforts, focusing on documenting steps taken and assisting with root cause analysis. Contribute to the documentation and adherence of established Service Level Objectives (SLOs) and Service Level Indicators (SLIs). Monitoring & Compliance: Maintain and use existing monitoring, logging, and alerting systems (e.g., Prometheus, Grafana, ELK stack) to ensure system health. Assist in managing and verifying CI/CD pipelines to ensure safe and efficient software releases. Support compliance efforts by ensuring operational procedures align with security best practices and regulatory requirements (HIPAA, SOC 2). Required Qualifications 8+ years of hands-on experience in a DevOps, Cloud Engineering, or SRE-focused technical role. Solid practical experience with AWS cloud provider services. Hands-on experience with Linux administration and troubleshooting. Proficiency in scripting languages such as Python, Bash, etc for automation. Solid experience with Infrastructure as Code tools such as Terraform. Experience with containerization technologies such as Docker and Kubernetes. Experience with monitoring systems like Prometheus, Grafana, AWS Cloud Watch. Experience with writing SQLs on PostgreSQL DB. Working understanding of core networking principles (VPC, routing, load balancing). Basic understanding of security and compliance requirements in a regulated industry (e.g., healthcare, finance). Preferred Qualifications Relevant certifications such as AWS Certified SysOps Administrator or AWS Certified Developer. Familiarity with CI/CD tools (e.g., Jenkins, GitLab CI). Compensation: $72 - $90 per hour ID#: 2508

Automotive Application Engineer Duration: 10+ Months Job Type: Temporary Assignment Work Type: Onsite Payrate:$ 66.00 - 66.00/hr. TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a recognized prominent global enterprise in the automotive sector, listed among the top 50 companies in the Global Fortune rankings. As a leading player in the global automotive industry, our client manufactures vehicles in 27 countries and effectively markets them across over 170 countries and regions worldwide. Job Description: The client's Production Engineering (PE) division's Manufacturing Innovation & Transformation (MIT) department is looking for a C#.NET web application developer to work as part of a Scrum team to build applications to improve efficiency and reduce lead time for the PE division's team members. Required Qualifications: Excellent communication and collaboration skills Ability and desire to learn new technologies and support the continuous improvement of the team's processes Working knowledge in developing C# .NET web applications (.NET core is a plus) Proficient in the following: React, Angular, MVC framework (At least one) Knowledge of Agile development methodologies, especially Scrum Must be prepared to show and/or discuss examples of previously developed systems/applications Experience designing relational databases Requirements: Additional Beneficial Qualifications: Experience using AI tools to enhance software development work Experience developing applications using a microservices architecture Experience working as part of a Scrum team Experience building web applications using Amazon Web Services (AWS) cloud services (or other cloud platforms) Proficient in the following: SQL Server, DocumentDB/MongoDB Automotive or other manufacturing/engineering industry experience TekWissen Group is an equal opportunity employer supporting workforce diversity.

Lead Product Security Engineer (R&D) Hybrid in Sorrento Valley - 3 days onsite What you will do: Maintain vigilance on industry security threats and manage risks according to established procedures. Define security requirements and controls based on use cases and threat models. Collaborate with cross-functional teams to integrate security into the product lifecycle. Establish automated processes for vulnerability scanning and remediation. Who you are: Bachelor's or Master's degree in Computer Science, Cybersecurity, or related field. 8-12 years of experience in product security or cybersecurity engineering. Demonstrated competency through certifications (e.g., CISSP, CompTIA Security+). Strong interpersonal and communication skills for cross-functional collaboration. Preferred: Experience in FDA-regulated environments and familiarity with cybersecurity standards (NIST, HIPAA, GDPR, etc.). Proficiency in scripting and test automation (PowerShell, Python). Knowledge of secure architecture design and incident response processes. What does this position pay? Compensation is determined by several factors which may include skillset, experience level, and geographic location. The expected range for this role is $170k to $195k per year. Please note this range is an estimate and actual pay may vary based on qualifications and experience. Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

Our client is seeking a skilled Cloud Application Engineer to join our on-site team in Garden City, NY. The ideal candidate has strong experience with AWS cloud infrastructure, solid SQL development skills, and exposure to .NET application environments. You will play a key role in designing, building, and maintaining our cloud-based systems that support enterprise applications and data services. ***THIS IS AN ONSITE POSITION. WILL REQUIRE RELOCATION TO THE NYC METRO AREA*** **NO C2C or SPONSORSHIP** You will play a key role in designing, building, and maintaining cloud-based systems that support a flagship site search product with a focus on scalability, reliability, and performance. This position is an excellent opportunity for someone who enjoys working across infrastructure and application layers, implementing automation and DevOps best practices, and delivering scalable, high-performance cloud solutions. Responsibilities Implement, maintain and troubleshoot AWS cloud infrastructure for scalability, reliability, and performance. Build and enhance CI/CD pipelines and deployment automation. Manage SQL databases, including backups, upgrades, migrations, performance monitoring, and troubleshooting. Collaborate with developers to automate deployment of and manually deploy .NET applications in the cloud environment. Implement infrastructure as code (IaC) using CloudFormation or Terraform. Monitor and troubleshoot production systems to ensure uptime and efficiency. Contribute to architecture and design discussions focused on cloud optimization and modernization. Required Qualifications Ideally targeting 2-5 years of relevant work experience. Strong hands-on experience with AWS services (e.g., EC2, RDS, S3, Lambda, ECS, CloudWatch, Cognito, IAM). Experience implementing DevOps practices including CI/CD automation and environment provisioning. Proficiency in SQL and database development best practices. Exposure to .NET (C#, ASP.NET, or .NET Core) and comfort collaborating with application teams. Familiarity with scripting and automation using PowerShell, Python, Go, or Bash. Strong understanding of cloud networking, security, and monitoring. Preferred / Nice-to-Have Skills Experience with microservices and containerization (Docker, Kubernetes). Knowledge of infrastructure-as-code and configuration management tools. Exposure to data pipelines or analytics workloads within AWS. Familiarity with BitBucket Pipelines, GitLab CI, GitHub Actions, Jenkins or other CI/CD systems. Experience with JIRA and Confluence.

Duration: 12 months Skills Required Role will be 100% onsite in Wilson, NC There will be 2 interviews; 1 video conference, and 1 will be onsite Bachelors degree is required This role is considered a Quality Management Platform Analyst Will assist with a plan, a template with utilizing software platform for method transfers and qualifications Must have Method Transfer knowledge/experience Must have Programming exp Required to have Kneat experience Work within the team to help develop the system Knowledge of method verification or method transfers Basic SQL exp, NOT coding Must have communication skills Must be self-driven CGMP exp Should have 8-10 years of exp MUST be able to show the candidate has used Kneat to generate protocols! Description: Quality Management Platform Analyst, located in Wilson, NC. We need a forward-thinking, data analyst, to evaluate, road map and construct an area within our workspace in Kneat to house our method verification and transfer execution worksheets protocols and reports Key Responsibilities: • Train on and establish an account in Kneat, • Evaluate how to optimally apply the system, • Construct the needed infrastructure in our workspace and roadmap the execution Qualifications Education: BS Experience • Incumbent must be proficient with Word, Excel, Power Point, have the soft skills needed to nurture change, as well as, the acuity to use software nuanced to operate in a regulated environment. - Generally Requires 8-10 Years Work Experience - Kneat experience required Preferred: A Major in Bio-Medical Engineering, Chemistry or Biology Other: Available to work full-time (40 hrs./week) with reliable transportation to and from work Must be available to work Monday through Friday 8AM to 5PM Must be able to work in the US and must not require sponsorship for employment visa status now or in the future (e.g., FI, H1-B status) Top Three Skills: Experience using Kneat, MS word and in writing method validation or transfer protocols 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 ************************ US 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: 25- 54461

AI Specialist Duration: 12 Month Contract Pay: $85-105/hr W2 ONLY, NO C2C Our client is at the forefront of technological innovation, dedicated to creating cutting-edge solutions that transform industries. We are seeking a highly skilled and motivated GAI Expert/Software Engineer to join our dynamic team. If you are passionate about generative AI, large language models (LLMs), and the latest advancements in agentic technologies, we want to hear from you! Job Description: As a GAI Expert/Software Engineer, you will be responsible for building an application that generates code, pipelines, and creates web applications automatically via prompts. You will leverage your expertise in generative AI and various LLM agentic technologies to experiment with and implement both current and future LLM technologies. This role requires a deep understanding of AI, machine learning, and software engineering principles. Required Qualifications: Bachelor's degree in computer science, Information Systems or related discipline; Or 8 years of prior equivalent work-related experience in lieu of a degree. Work experience in addition to degree: 2 - 3 years of real hands-on GAI implementations and 4 - 5 years of software engineering. Key Responsibilities: Design, develop, and sustain innovative AI and LLM-driven solutions that advance strategic customer initiatives and operational goals. Explore, implement, and refine emerging agentic LLM technologies to support the continuous evolution of organizational capabilities and digital transformation. Partner with cross-functional teams and business stakeholders to accelerate the adoption and impact of insights generated through advanced AI modeling Implement GAI as per AI Policies. Stay up-to-date with the latest advancements in generative AI and LLM technologies, and apply this knowledge to drive innovation. Conduct research and development to explore new AI techniques and methodologies and future tech like Block chain and Quantum computing. Optimize and fine-tune AI models for performance, scalability, and accuracy. Provide technical guidance and mentorship to junior team members. Preferred Qualifications: Proven experience in software engineering, with a focus on AI and machine learning. Experience with agentic technologies and their applications. Knowledge of natural language processing (NLP) and computer vision. Experience with DevOps practices and tools for continuous integration and deployment. Appetite to research and keep up to various generative AI products and large language models (LLMs). Strong programming skills in languages such as Python, React, Angular. Strong knowledge in AWS platform. Excellent problem-solving skills and the ability to think critically and creatively. Strong communication and collaboration skills.

- CAD Engineer RATE- $50/hr Job descriptions: - 10+ years of experience required EDA Semiconductor Design Enablement Responsible for supporting and optimizing Electronic Design Automation (EDA) tools and flows used in silicon design. This role bridges design teams and infrastructure, ensuring high availability, performance, and scalability of CAD environments across front-end and back-end workflows.

AI Engineer Troy MI (Onsite) Long term Contract Required Qualifications Bachelor's or Master's degree in Computer Science, Engineering, Data Science, or related field Professional experience in AI/GenAI and LLM implementation using Python Libraries Hands-on experiences in prompt engineering techniques (Few-Shot, Chain of Thought prompting, RAG), embeddings, and similarity search) Machine Learning and Natural Language Processing (NLP) Preferred Qualifications Proficiency in Databricks, cloud computing, and the Azure environment Proficiency with libraries such as LangChain and OpenAI Experience with Model Context Protocol (MCP) and Multi-Agent Framkeworks Experience with open-source LLMs (e.g., Llama) and training smaller models Product or project management experience Bonus Qualifications Knowledge of Azure Power Apps and Web Apps Experience in requirements management and test case development according to Automotive SPICE

Process and Automation Engineer Domestic & International Travel: Yes, 30-50% Contract Type: 6-Month Contract-to-Hire Company: Brooksource Engineering (On-site at a pharmaceutical manufacturing client) Compensation: $65/hour ++ Position Overview As a Process and Automation Engineer, you will focus on defining, validating, and optimizing high-speed assembly and packaging processes for pharmaceutical products. This role emphasizes mechanical systems, process characterization, and regulatory compliance while supporting major capital projects for new product launches and capacity expansions. You will collaborate with OEMs and internal teams to ensure robust process design, seamless equipment integration, and adherence to qualification standards (IO/OQ/PQ). Key Responsibilities Process Design & Optimization: Develop and refine process flows for automated assembly and packaging lines, ensuring throughput, reliability, and quality. Equipment Integration Oversight: Partner with OEMs to confirm mechanical and process requirements are met during design and installation. Engineering Studies & Characterization: Define and execute studies to characterize unit operations, establish operating ranges, and validate process capability. Risk Analysis & Mitigation: Apply FMEA and other risk assessment tools to identify and mitigate process and patient risks. Qualification & Validation: Lead or support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new equipment and processes, ensuring compliance with cGMP and regulatory standards. Performance Analysis: Use statistical methods and process data to identify bottlenecks, optimize cycle times, and improve efficiency. Documentation & Compliance: Author and maintain process documentation, including SOPs, process flow diagrams, validation protocols, and qualification reports. Continuous Improvement: Drive Kaizen and OPEX initiatives to enhance process reliability and reduce cost of goods. Mentorship: Provide guidance to junior engineers on process validation strategies and best practices. Minimum Qualifications Process Engineering Expertise: Experience in mechanical assembly processes, high-speed packaging systems, and process optimization. Capital Project Delivery: Proven ability to support large-scale process implementation projects in regulated environments. Validation Knowledge: Hands-on experience with IO/OQ/PQ protocols and execution. Preferred Qualifications Familiarity with cGMPs, commissioning, and qualification processes. Experience with DOE, GR&R, and statistical analysis for process improvement. Understanding of automation systems and their impact on process performance. B.S./M.S. in Mechanical, Chemical, or Industrial Engineering (or equivalent experience). Additional Information Travel: Up to 25% on average, with peaks exceeding 50% during major project phases.

Our client is a global leader in the development and manufacture of pharmaceutical ingredients/chemicals. This role offers a chance to join a highly respected organization known for its technical excellence, strong scientific culture, and deep expertise across all operational processes. Location: Lake County, OH Salary: $100-125K Schedule: 1st Shift, Monday-Friday (Onsite) Relocation Assistance Provided Essential Responsibilities Collaborate closely with chemists to guide the development of new chemical processes, translating R&D concepts into clear, executable manufacturing instructions. Lead the scale-up of production processes from laboratory bench to pilot-plant operations. Troubleshoot and propose flexible solutions when scale-up challenges arise; work hands-on with production operators to resolve issues. Support fellow engineers with complex scale-up scenarios. Prepare and maintain key documentation including batch records, specifications, hazard assessments, safety review packages, emissions data, and process reports. Conduct safety meetings, oversee ongoing production, assist on the manufacturing floor as needed, and review completed batch records. Work closely with chemistry and quality teams throughout the entire production cycle. Interface with external stakeholders such as clients, vendors, and contractors. Provide engineering support for pilot-plant equipment and infrastructure. Manage multiple priorities and work with leadership to set and adjust project goals. Required Education & Experience B.S. or M.S. in Chemical Engineering or Chemistry. 10+ years of experience in process scale-up and preparation within the pharmaceutical or specialty chemicals industries. Key Skills & Qualifications Effective collaborator within multi-disciplinary teams. Strong analytical and problem-solving skills. Proven experience with first-time scale-ups. Demonstrated performance and progression in previous roles. Hands-on experience with pilot-plant and kilo-scale equipment. Knowledge of process validation, cleaning validation, and equipment commissioning/qualification. Excellent troubleshooting capabilities. Highly motivated, team-oriented, and skilled in both written and verbal communication.

Salary: $80-$95/k DIRECT HIRE This position is responsible for developing and executing plans for optimizing process control and instrumentation systems throughout the plant. This position will provide technical support for a wide variety of instrumentation and control equipment. The position will drive automation strategy, manage capital and projects improvement projects, and provide technical leadership in troubleshooting and continuous improvement initiatives. Essential Functions & Responsibilities: Manage, mentor, and develop technicians. Set clear objectives, priorities, and performance expectations for the team. Foster a culture of safety, quality, and continuous improvement. Oversee design, commissioning, and validation of automation systems. Develop and maintain site automation standards, specifications, and documentation. Lead programming and troubleshooting for distributed controls systems and PLCs. Develop and review electrical and other drawings in support of plant processes. Direct the preventive maintenance, calibration, and troubleshooting of process instrumentation in compliance with GMP and regulatory requirements. Support and participate in internal and external audits, providing technical expertise and documentation as required. Drive root cause analysis and corrective/preventive actions (CAPAs) for automation and instrumentation-related deviations. Identify and implement opportunities for process optimization, energy savings, and enhanced reliability. Education, Experience, and/or Skill: Bachelor's degree in electrical Engineering, or related field required Minimum 8 years of automation engineering experience in a GMP-regulated environment At least 2-5 years of direct people management experience Experience in programming, maintaining and troubleshooting Distributed Control Systems Strong background in standard PC applications Strong project management skills Knowledge in computer validation All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

ESSENTIAL DUTIES AND RESPONSIBILITIES The essential functions include, but are not limited to the following: · Support the execution of the Commissioning, Qualification, and Validation activities for our new Vial Filling system (e.g., washing/depyrogenation, aseptic filling, isolator/VPHP, glove integrity testers, environmental monitoring systems), including SAT, IQ/OQ, PQ, and Aseptic Process Simulation. · Management of Equipment Vendors, including project execution, on-site maintenance and calibration visits, vendor-supplied training of operation and maintenance staff, management of continuous improvement projects, and spare parts criticality assessments. · Responsible for delivering cycle development for the process including VPHP cycles for Isolator & transport systems, and preparation of required GMP documentation for filling process and recipes. · Support the establishment of an electronic batch record system for filler and isolator setup, operation, and changeover. · Support the transition from project to sustaining manufacturing and the ramp-up of production volumes in the future by improving equipment reliability through Continuous Improvement and TPM processes. · Coordinate technical deliverables within the Aseptic Operations team to support successful process and product launches. · Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA. · Manage change in the Vial Filling and/or Nest Filling areas as per site change control procedures. · Participate in regulatory inspections e.g. FDA, DEA inspections as a Subject Matter Expert (SME). BASIC QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES) · Bachelor's degree in engineering, Materials Science, Biology, or related discipline. · Minimum 4+ years working in a cGMP environment, i.e. pharmaceutical, medical device. · Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment. · Front-line support of aseptic filling equipment and/or barrier systems, e.g. isolator or RABS. · Demonstrated ability to solve technical problems and implement projects. · Excellent interpersonal and communication skills across various levels of the organization. · Strong Mechanical Aptitude. · Interact with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects. · Ability to execute on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches. · Willingness to adapt to changing priorities as project demands change. · Ability to explain complex technical issues to external customers/agencies. PREFERRED QUALIFICATIONS · SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS). · Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications. · Demonstrated management and delivery of large capital projects ($1MM +). · Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.

The Senior Project Engineer is responsible for ensuring administrative, contractual, financial and technical aspects of the assigned project(s) being executed. Senior Project Engineer will be reporting to the Project Manager and/or Superintendent. The Senior Project Engineer will supervise a team of skilled Project Engineer professionals who support departmental and organizational goals through their efforts. Job Responsibilities includes (but may not be limited to): Assists Project Manager and Superintendent in the management of construction projects, which involves cost control, expediting, quantity take-off, scheduling and safety. Develop peer constructability review of design documents. Develop, input and update project schedule as directed. Assist with the coordination, development and accuracy of the project estimate, budget, revisions, cost coding, and prepare cash flow charts. Analyze changes to contract documents, i.e. Owner Change Order Requests (CORs), Subcontractor Change Orders (SCOs). Review revised cost reports with Project Manager and assist in establishing final costs.Attend and participate in monthly job reviews. Work with Project Manager to perform a thorough and objective bid analysis using all applicable components. Prepare subcontractor Schedule of Values and monthly owner billings with Project Manager and Project Superintendent. Other duties upon request. Qualifications: 4+ years of experience as a Project Engineer in commercial construction industry. Bachelor's degree in Construction Management of Engineering or related field. Proficient computer skills in Microsoft Office Suite, Project Management software (Viewpoint or similar) and Scheduling software (Primavera or similar). Apply a complete and proficient understanding of construction management, engineering, safety, scheduling, estimating, budgets, costing and procurement. Analyzing and interpreting data. Effective verbal and written communication skills. Multi-tasking in a fast paced environment. Strong leadership, detail oriented, problem solving, initiative and teamwork. Proven ability to fulfill project development to project closeout responsibilities. Working Conditions: Duties required physical abilities such as repetitive hand/finger motions, arm extensions, sitting, standing, and walking jobsites that include uneven and changing site conditions. As well as climbing stairs and ladders, etc. The individual is required to occasionally move around the office and constantly operate a computer and other office machinery, etc. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. Level 10 Construction is an Equal Opportunity Employer M/F/Disability/Veterans. All applicants applying must be authorized to work in the United States.

Secret clearance or higher Chantilly, Virginia Performs assignments of a routine degree of complexity by compiling and evaluating design and test data, preparing technical specifications, analyzing technical data to determine appropriate limits and variables for electrical/electronic systems, components, equipment, and networks. Assists in the interpretation of results and writing of small sections of technical reports. Completes assigned project work within schedule and budget constraints. THE FOLLOWING IS REQUIRED Bachelor's in Computer Science, Computer Engineering, Electrical Engineering, or related field of study and (+2) years of experience, OR Master's degree in a relevant field, OR an equivalent combination of education/experience in a relevant field Develop software to run in user-mode or kernel-mode Ability to code in C or C++ Ability to use a scripting language (Python, Perl, Ruby, etc.) Experience with PC and embedded systems architecture to include boot processes and OS internals Experience with a disassembler for vulnerability research (IDA Pro, BinaryNinja, etc.) Understand network protocols Experience with one or more assembly languages (x86, x64, ARM, MIPS, PowerPC, etc.) Experience with one or more debuggers (WinDbg, OllyDbg, gdb, etc.) Experience with vulnerability research on one or more operating systems: Android, iOS, Windows, Linux, MacOS, VxWorks, QNX, RTOSs, or other custom operating systems Ability to demonstrate good organization, documentation, communication, problem-solving, and teamwork skills Knowledge of common mitigation techniques (DEP, ASLR, etc.) Familiarity with fuzzers Must be a sole US citizen with an active DoD Secret security clearance THE FOLLOWING IS DESIRED Participation in CTFs Ability to analyze assembly-level code on multiple platforms (x86, x64, ARM, MIPS, PowerPC, etc.) Experience with symbolic analysis Ability to analyze network protocols throughout all layers of the network stack Background in software engineering and architecture