Manufacturing Engineer jobs at HKA Enterprises

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

Job Title: Manufacturing Engineer Terms: 6-month contract (possible extension) Schedule: Sat-Wed, 7:00 AM-4:30 PM EST (flexible with advance notice) Pay Rate: $40-$50/hr (Without benefits) Top Skills Needed: AutoCAD (2024), CREO, or SolidWorks for visualization and design Process definition: time studies, work instructions, line execution improvements Engineering degree preferred (ME ideal; Supply/Industrial/other engineering also considered) Experience with line architecture & industrial processes Role Responsibilities: Support process design/layout, mechanical/manufacturing engineering, tooling, and safety Address daily and long-term manufacturing issues using PFMEA, Control Plans, 8D, SAP, etc. Contribute to new product development, cost estimates, design concepts, and process layouts Assist with tooling, fixtures, equipment design, and capital expenditure planning Improve processes, ergonomics, safety, and material handling Provide key on-floor support, drive problem resolution, and lead improvement projects Preferred Qualifications: Bachelor's degree in Engineering (ME/EE preferred) 3-5 years of relevant manufacturing experience Strong communication and project management skills

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!

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

TITLE: Machine Learning Engineer ANTICIPATED DURATION: 1+ years Rate: $70-85/hr W2 only - no C2C Responsibilities: Design and build modular, reusable AI components that can be scaled across business units Lead development of scalable RAG-based solutions for document comparison (e.g., contracts vs. invoices) Engineer multi-agent systems for intelligent task coordination and decision support Develop transcription and NLP pipelines for customer interaction analysis Build and fine-tune models using frameworks like PyTorch, Transformers, or LangChain Package models for deployment in Azure ML, ensuring scalability and maintainability Collaborate with MLOps, DevOps, and data engineering teams to align on infrastructure and deployment patterns Contribute to shared libraries, APIs, and templates that accelerate AI product delivery Ensure AI products meet enterprise-grade security and compliance standards Implement monitoring for model performance, data drift, and usage metrics Requirements: Bachelor's or Master's in Computer Science, AI, Data Science, or related field 5+ years in AI/ML engineering or applied machine learning Experience building production-grade AI systems in cloud environments (Azure preferred) Strong Python skills; experience with LLMs, RAG, and agent frameworks Familiarity with Azure ML, Databricks, and MLflow Experience with NLP, speech-to-text, and document intelligence Proficiency in SQL and big data tools (Spark, Kafka) Preferred Experience: Designing multi-agent architectures or orchestration frameworks Familiarity with LangChain, OpenAI APIs, or similar LLM tooling Experience designing front-end GUIs for chat interfaces Certifications in Azure AI or ML engineering Experience in multi-business or federated enterprise environments Agile development experience and comfort with iterative delivery The hourly pay rate range for this position is $70.00 to $85.00 (dependent on factors including but not limited to client requirements, experience, statutory considerations, and location). Benefits available to full-time employees: medical, dental, vision, disability, life insurance, 401k and commuter benefits. Synergis is proud to be an Equal Opportunity Employer. We value diversity and do not discriminate on the basis of race, color, ethnicity, national origin, religion, age, gender, gender identity, political affiliation, sexual orientation, marital status, disability, military/veteran status, or any other status protected by applicable law. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the requirements of applicable state and local laws, including but not limited to, the San Francisco Fair Chance Ordinance, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the California Fair Chance Act. For immediate consideration, please forward your resume to *********************. If you require assistance or an accommodation in the application or employment process, please contact us at *********************. Synergis is a workforce solutions partner serving thousands of businesses and job seekers nationwide. Our digital world has accelerated the need for businesses to build IT ecosystems that enable growth and innovation along with enhancing the Total Experience (TX). Synergis partners with our clients at the intersection of talent and transformation to scale their balanced teams of tech, digital and creative professionals. Learn more about Synergis at *******************

- 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.

Title- Cloud Developer Engineer with AWS + GCP experience Type- Full Time Position JD: Must have the latest DevOps, cloud, and Kubernetes experience of AWS & GCP. Design, build, and maintain CI/CD pipelines for applications deployed on AWS and GCP. Manage Kubernetes clusters, including deployment, scaling, monitoring, and troubleshooting. Automate infrastructure provisioning using tools such as Terraform, CloudFormation, or Deployment Manager. Implement robust monitoring, logging, and alerting solutions for cloud environments and containerized workloads. Collaborate with development teams to optimise application performance and reliability. Ensure security best practices are followed for cloud resources, container images, and network configurations. Perform cost optimisation and resource management for multi-cloud deployments. Participate in disaster recovery planning and implementation

JOB TITLE: Assistant Process Engineer Duration: 6 months initial (potential extension/potential right to hire) The client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. We are developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. We are looking for a Associate Engineer to join the raw materials team within the CTTO (Cell Therapy Technical Operations) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production. Responsibilities include, but are not limited to, the following: ● Support as a SME for raw materials including single-use systems (SUS) and material sciences. ● Provide technical support on in CAR-T commercial manufacturing. ● Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications. ● Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials. ● Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes. ● Vendor management including change controls, audits, deviations, and QRM programs. ● Support investigations and ensure compliance with internal standards and requirements. ● Perform technical diligence visits to raw material supplier sites with cross-functional teams. ● Provide necessary technical analysis to support impact assessments and investigations. ● Support responses for Information Request (IR) from regulatory bodies. Skills/Knowledge Required: • B.S. with 0+ years of experience or M.S. with 0+ years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent. • Exposure to raw materials (both liquid and single use system). • Understanding of regulatory/compendial requirements for raw materials used in biomanufacturing. • Experience working with vendors and contract manufacturing sites. • Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. • Data management skills and comprehension skills of technical documents, such as process description documents. • Ability to assess risk and develop contingency plans for process risks. • Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities. • Detail oriented with excellent verbal and written communication skills. • Strong interpersonal and leadership skills to work with teams in different functions and organizations. • Experience with Quality Management System (Ex. Deviation, CAPA, Change Management). • Knowledge of GMP manufacturing practices and documentation requirements. PREREQUISITES Experience in Single Use Systems, GMP experience, Data Management Additional Skills: • Understanding of key considerations for single-use containers used for raw materials. • Familiarity with raw material supply chains and manufacturing methods. • Data management and grasp apprehension of technical instructions • Lean Manufacturing experience is desired. If hired, you will enjoy the following Eclaro Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to *************** or call *************. Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

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.

JOB TITLE: Assistant Process Engineer Duration: 6 months initial (potential extension/potential right to hire) The client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. We are developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. We are looking for a Associate Engineer to join the raw materials team within the CTTO (Cell Therapy Technical Operations) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production. Responsibilities include, but are not limited to, the following: ● Support as a SME for raw materials including single-use systems (SUS) and material sciences. ● Provide technical support on in CAR-T commercial manufacturing. ● Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications. ● Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials. ● Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes. ● Vendor management including change controls, audits, deviations, and QRM programs. ● Support investigations and ensure compliance with internal standards and requirements. ● Perform technical diligence visits to raw material supplier sites with cross-functional teams. ● Provide necessary technical analysis to support impact assessments and investigations. ● Support responses for Information Request (IR) from regulatory bodies. Skills/Knowledge Required: • B.S. with 0+ years of experience or M.S. with 0+ years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent. • Exposure to raw materials (both liquid and single use system). • Understanding of regulatory/compendial requirements for raw materials used in biomanufacturing. • Experience working with vendors and contract manufacturing sites. • Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. • Data management skills and comprehension skills of technical documents, such as process description documents. • Ability to assess risk and develop contingency plans for process risks. • Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities. • Detail oriented with excellent verbal and written communication skills. • Strong interpersonal and leadership skills to work with teams in different functions and organizations. • Experience with Quality Management System (Ex. Deviation, CAPA, Change Management). • Knowledge of GMP manufacturing practices and documentation requirements. PREREQUISITES Experience in Single Use Systems, GMP experience, Data Management Additional Skills: • Understanding of key considerations for single-use containers used for raw materials. • Familiarity with raw material supply chains and manufacturing methods. • Data management and grasp apprehension of technical instructions • Lean Manufacturing experience is desired. If hired, you will enjoy the following Eclaro Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to *************** or call *************. Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

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.

CEI is a rapidly expanding leading end-to-end Solutions provider driving transformation and innovation for our customers to help harness change to gain competitive advantage through Advisory Services, Custom Software Solutions, Application Management and Staffing Solutions. What we're looking for: CEI's Custom Applications Division is seeking a Lead Machine Learning Engineer to build efficient, data-driven artificial intelligence systems that advance our predictive automation capabilities. The candidate should be highly skilled in statistics and programming, with the ability to confidently assess, analyze, and organize large amounts of data. Responsibilities: Study and transform data science prototypes and apply appropriate machine learning algorithms and tools Run machine learning tests and experiments, and document findings and results Train, retrain, and monitor machine learning systems and models as needed Construct optimized data pipelines to feed machine learning models Consult with managers to determine and refine machine learning objectives Extend existing machine learning libraries and frameworks Qualifications and Requirements: Extensive math and computer skills, with a deep understanding of probability, statistics, and algorithms In-depth knowledge of machine learning frameworks, like Keras or PyTorch Familiarity with data structures, data modeling, and software architecture Proven experience as a machine learning engineer or similar role Familiarity with Python, Java, and R Excellent communication and collaboration skills Innovative mind with a passion for continuous learning General knowledge of building machine learning systems Bachelor's degree (or equivalent) in computer science, mathematics, or related field

Job Title: Machine Learning Lead Engineer Duration: 6 month Contract-to-Hire Education/Experience Required: Leading ML/DS projects in an industrial setting, experience working with time-series data and SCADA applications. Job Description & Responsibilities : Lead end-to-end delivery of data engineering and machine learning projects that improve operational efficiency and reduce emissions in natural gas development, production, and midstream operations. Own the full lifecycle of ML solutions from ideation and scoping, to data discovery, modeling, validation, deployment, and long-term monitoring. Provide technical leadership for a small but high-impact Data Engineering & Machine Learning team, including mentoring, code reviews, and setting best practices for quality and reliability. Work on-site with engineering, operations, and SCADA teams on-site to understand real-world constraints, define use cases, and translate business problems into data-driven solutions. Lead the effort to productionize existing models and scale multiple proof-of-concept solutions into robust, maintainable, and observable production systems. Architect, design, and implement data pipelines that ingest, clean, transform, and store large volumes of time-series and event data from SCADA systems, field sensors, and other industrial data sources. Develop and refine machine learning models focused on time-series problems such as forecasting, anomaly detection, remaining useful life estimation, and performance optimization of assets. Contribute to and help lead Digital Twin Analytics initiatives, integrating physics-based and data-driven models to simulate and optimize complex systems in the field. Collaborate on the design and implementation of anomaly detection frameworks that surface early warning signals for equipment failure, process instability, and emissions events. Partner with software and DevOps engineering to design and implement MLOps practices, including CI/CD for ML, feature stores, model versioning, model performance tracking, and automated retraining pipelines. Establish standards for model validation, A/B testing, and offline/online evaluation to ensure robustness and reliability in operational environments. Communicate technical concepts, tradeoffs, and results clearly to both technical stakeholders and non-technical operations leaders, including presenting insights and recommendations to leadership. Evaluate new tools, libraries, and cloud-native services in the data and ML ecosystem and make recommendations to improve performance, scalability, and developer productivity. Champion a culture of experimentation, data quality, and continuous improvement while keeping a strong focus on safety, regulatory compliance, and environmental impact. Skills & Qualifications : Bachelor's degree in Computer Science, Data Science, Engineering, Applied Mathematics, or a related field; a graduate degree is preferred but not required with sufficient experience. 7+ years of hands-on experience in Data Science, Machine Learning, or Data Engineering, with at least 2+ years in a lead or senior role driving projects from concept to production. Strong proficiency in Python for data engineering and machine learning, including experience with common data and ML libraries (for example pandas, NumPy, scikit-learn, PyTorch or TensorFlow, statsmodels). Strong SQL skills and experience working with relational databases, time-series databases, or data warehouses for large-scale analytics. Proven experience working with time-series data in industrial or operational settings, including feature engineering, resampling, handling missing data, and building time-series forecasting or anomaly detection models. Experience integrating and analyzing SCADA data or similar industrial control and telemetry systems in energy, utilities, manufacturing, or related heavy industry. Solid understanding of data engineering concepts including ETL/ELT pipelines, batch and streaming architectures, and data modeling for analytical workloads. Hands-on experience with cloud platforms (such as AWS, Azure, or GCP) and modern data tooling, for example cloud storage, managed databases, containerization, and workflow orchestration tools. Practical exposure to MLOps practices, including deployment of models to production, monitoring model performance in real time, and maintaining models over their lifecycle. Familiarity with concepts and techniques related to Digital Twin Analytics, physics-informed models, or asset performance management in an industrial context is a strong plus. Strong software engineering fundamentals including version control (Git), code review practices, testing, and documentation. Demonstrated ability to lead cross-functional initiatives, prioritize a portfolio of projects, and manage stakeholder expectations in a fast-moving environment. Excellent communication skills, with the ability to explain complex technical concepts clearly and to influence decision making among operations leaders, field engineers, and executives. Willingness to work on-site in the Pittsburgh, PA area and periodically visit field or plant locations as needed; relocation support is available for exceptional candidates.

About Us: We are working with a mission-driven SaaS company dedicated to keeping people safe. They're passionate about public safety and strive to create innovative solutions that keep their customer's happy. Job Description: As a Senior Staff Engineer, you will play a crucial role in building and maintaining our cutting-edge web applications. You will work closely with our engineering team to design, develop, and deploy robust, scalable, and user-friendly features. Onsite in Tampa, FL Area Up to 220k base salary Responsibilities: Design, develop, and maintain backend applications using Ruby on Rails. Build user-friendly and responsive frontend interfaces using React. Collaborate with cross-functional teams to define and implement new features. Write clean, well-tested, and efficient code. Qualifications: Strong proficiency in Ruby on Rails, React, and React Native. Experience with relational databases (e.g., PostgreSQL). Solid understanding of JavaScript and web development fundamentals. Familiarity with RESTful APIs and microservices architecture.

Project Engineer (Change Management) - Onsite in Aiken, SC Duration: 12 months Work Authorization: USC/GC Only Seeking an experienced Project Engineer with a strong background in Change Management/Change Control, Engineering Quality, and Systems Engineering-specifically within nuclear and EPC environments. This is not a field construction role. The ideal candidate has engineering experience supporting construction and fabrication projects, not hands-on field construction. Basic Requirements Bachelor's degree in Engineering (4-year accredited degree required). 10+ years of related engineering or project experience. Experience in construction management, fabrication environments, or EPC projects. Strong experience in Change Management/Change Control. Strong communication skills to work with management, clients, vendors, and internal teams. Ability to apply technical knowledge, follow regulations, and manage documentation. Detail-oriented, organized, and able to work in time-sensitive environments. Preferred Qualifications 6+ years in engineering, procurement, fabrication, construction (EPFC/CM) environments. Experience working in nuclear industry projects. Background in risk assessment initiatives. Successful project engineering experience on at least two medium or large projects. Knowledge of engineering software tools and databases. Strong analytical, problem-solving, and technical writing skills. PMP certification (preferred but not required). Ability to adapt to changing environments and take on new challenges. Customer-focused mindset with the ability to build strong relationships.

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