StaffingALL.com

Job Title: Automation Engineer (opt/cpt) Location: USA (Multiple States) Employment Type: Full-Time Visa Status: Any visa accepted, H1B sponsorship available Email resume: Staffingalljobs@gmail.com Job Overview: We are looking for a skilled Automation Engineer to join our team in the pharmaceutical or medical device industry. The Automation Engineer will be responsible for designing, developing, and implementing automation systems to enhance manufacturing processes, improve efficiency, and ensure compliance with regulatory standards. The ideal candidate will have strong technical expertise in automation technologies, as well as experience in a regulated environment. Key Responsibilities: • Design and develop automation systems for manufacturing processes, including PLC, SCADA, and DCS systems. • Implement automation solutions to optimize production efficiency and reduce operational costs. • Collaborate with cross-functional teams, including manufacturing, quality assurance, and engineering, to identify automation opportunities and requirements. • Troubleshoot and resolve automation system issues, ensuring minimal downtime and maximum productivity. • Conduct system testing, validation, and documentation to ensure compliance with cGMP and FDA regulations. • Provide technical support and training to manufacturing personnel on automation systems and processes. • Stay updated on industry trends and advancements in automation technology and recommend improvements to existing systems. Requirements: • 2+ years of experience as an Automation Engineer in the pharmaceutical, medical device, or life sciences industry. • Strong knowledge of automation technologies, including PLC programming, SCADA systems, and control systems. • Familiarity with regulatory requirements, including cGMP and FDA standards. • Excellent problem-solving skills, analytical thinking, and attention to detail. • Ability to work independently and collaboratively in a team environment. • Proficient in relevant software tools and programming languages used in automation (e.g., Ladder Logic, Structured Text). Location: • Multiple openings available across the East Coast (Maryland, Virginia, New Jersey, Delaware, and Washington DC). Visa and Sponsorship: • Any visa is acceptable. • H1B sponsorship is available for qualified candidates. How to Apply: Please send your resume to staffingalljobs@gmail.com with the subject line “Automation Engineer Application.”

Job Title: Senior Automation Engineer Location: East Coast, USA (Multiple States) Employment Type: Full-Time Visa Status: Any visa accepted, H1B sponsorship available Job Overview: We are seeking a highly experienced Senior Automation Engineer to lead automation initiatives within our pharmaceutical or medical device manufacturing operations. The Senior Automation Engineer will be responsible for designing, implementing, and optimizing advanced automation systems to enhance operational efficiency, ensure product quality, and maintain compliance with regulatory standards. The ideal candidate will possess strong technical skills, leadership abilities, and a proven track record in automation engineering. Key Responsibilities: • Lead the design and implementation of complex automation systems, including PLC, SCADA, and DCS solutions for manufacturing processes. • Collaborate with cross-functional teams to identify automation opportunities, assess requirements, and develop effective solutions. • Provide technical guidance and mentorship to junior engineers and technical staff, fostering a culture of innovation and continuous improvement. • Conduct system testing, validation, and documentation to ensure compliance with cGMP and FDA regulations. • Troubleshoot and resolve complex automation issues, optimizing system performance and minimizing downtime. • Evaluate and recommend new technologies and tools to enhance automation capabilities and operational efficiency. • Prepare and maintain project documentation, including design specifications, validation protocols, and user manuals. • Support internal and external audits, ensuring all automation systems meet compliance standards. Requirements: • 5+ years of experience as an Automation Engineer in the pharmaceutical, medical device, or life sciences industry. • Extensive knowledge of automation technologies, including PLC programming, SCADA systems, DCS, and control system design. • Strong understanding of regulatory requirements, including cGMP and FDA standards. • Proven leadership skills with the ability to manage projects and mentor team members effectively. • Excellent problem-solving abilities, analytical skills, and attention to detail. • Proficient in relevant programming languages and software tools used in automation (e.g., Ladder Logic, Structured Text, HMI development). Location: • Multiple openings available across the East Coast (Maryland, Virginia, New Jersey, Delaware, and Washington DC). Visa and Sponsorship: • Any visa is acceptable. • H1B sponsorship is available for qualified candidates. How to Apply: Please send your resume to staffingalljobs@gmail.com with the subject line “Senior Automation Engineer Application.”

Job Title: Automation Engineer Location: East Coast, USA (Multiple States) Employment Type: Full-Time Visa Status: Any visa accepted, H1B sponsorship available Job Overview: We are looking for a skilled Automation Engineer to join our team in the pharmaceutical or medical device industry. The Automation Engineer will be responsible for designing, developing, and implementing automation systems to enhance manufacturing processes, improve efficiency, and ensure compliance with regulatory standards. The ideal candidate will have strong technical expertise in automation technologies, as well as experience in a regulated environment. Key Responsibilities: • Design and develop automation systems for manufacturing processes, including PLC, SCADA, and DCS systems. • Implement automation solutions to optimize production efficiency and reduce operational costs. • Collaborate with cross-functional teams, including manufacturing, quality assurance, and engineering, to identify automation opportunities and requirements. • Troubleshoot and resolve automation system issues, ensuring minimal downtime and maximum productivity. • Conduct system testing, validation, and documentation to ensure compliance with cGMP and FDA regulations. • Provide technical support and training to manufacturing personnel on automation systems and processes. • Stay updated on industry trends and advancements in automation technology and recommend improvements to existing systems. Requirements: • 2+ years of experience as an Automation Engineer in the pharmaceutical, medical device, or life sciences industry. • Strong knowledge of automation technologies, including PLC programming, SCADA systems, and control systems. • Familiarity with regulatory requirements, including cGMP and FDA standards. • Excellent problem-solving skills, analytical thinking, and attention to detail. • Ability to work independently and collaboratively in a team environment. • Proficient in relevant software tools and programming languages used in automation (e.g., Ladder Logic, Structured Text). Location: • Multiple openings available across the East Coast (Maryland, Virginia, New Jersey, Delaware, and Washington DC). Visa and Sponsorship: • Any visa is acceptable. • H1B sponsorship is available for qualified candidates. How to Apply: Please send your resume to staffingalljobs@gmail.com with the subject line “Automation Engineer Application.”

Job Title: JR Automation Engineer Location: Orange Drive Davie FL 33314 Email: Staffingalljobs@gmail.com 1. Recent college graduated within the last 1 year. Master's Degree minimum in electrical engineering, computer sciences, automation and controls. 2. Min 1 year experience working with PLCs and SCADA. 3. Background and experience on networking as we are interconnecting and adding equipment to industrial network. 4. Min 1 year experience working in GMP-regulated environment (preferred but not required pharmaceutical and medical devices), 5. Preferred experience on Computer Systems Validation (CSV) and project management would be a plus. Core Essential skill sets required: 1. College graduated with Master's Degree with at least 3-5 years of experience within automation and controls fields. Master's Degree minimum in electrical engineering, computer sciences, automation and controls. 2. Min 3-5 year experience working with PLCs, SCADA, control systems, robotics, computers, etc. 3. Background and experience on networking as we are interconnecting and adding equipment to industrial network. 4. Min 1-3 year experience working in GMP-regulated environment (preferred but not required pharmaceutical and medical devices), 5. Preferred experience on Computer Systems Validation (CSV) and project management would be a plus.

Job Title: Automation Engineer Location: Orange Drive Davie FL 33314 Duration: 10/28/2024 to 04/25/2025 Shift: Monday - Friday 8:00am - 5:00pm Temp to Perm: Yes Email: Staffingalljobs@gmail.com Job Summary: We are seeking a skilled Automation Engineer to join our dynamic team. The ideal candidate will be responsible for designing, developing, and implementing automated systems to improve the efficiency, reliability, and performance of our operations. This role requires a strong understanding of automation technologies, problem-solving skills, and the ability to work collaboratively with cross-functional teams. Key Responsibilities: o Design and develop automation systems and solutions based on operational requirements and technical specifications. o Develop and maintain automated test scripts and frameworks to ensure system functionality and performance. o Implement and configure automation solutions in a variety of environments, including manufacturing, production, and IT systems. o Integrate automation systems with existing infrastructure and software applications. o Monitor and analyze automation systems to identify and resolve issues promptly. o Provide technical support and troubleshooting for automation systems. o Continuously evaluate and improve automation processes to enhance performance and reduce costs. o Develop and execute test plans, test cases, and test scripts to verify system functionality. o Train and mentor team members and end-users on automation tools and best practices. o Ensure that automation systems comply with industry standards, regulations, and company policies. Qualifications: • Education: Bachelor’s degree in industrial/electrical engineering, Computer Science, or a related field. A master’s degree is a plus. • Experience: 3-5 years of experience in automation engineering or a related field. • Technical Skills: Proficiency in automation tools and technologies such as PLCs, SCADA systems, and programming languages (e.g., Python, Java, C#). • Knowledge: Strong understanding of control systems, process automation, and industrial networking. • Analytical Skills: Excellent problem-solving and analytical skills with a detail-oriented approach. • Communication: Strong written and verbal communication skills with the ability to work effectively in a team environment.

Job title: Equipment Qualification Location: Upstate, NY Email: Staffingalljobs@gmail.com Job Description We are seeking two Equipment Validation/Qualification Contractors to support an expansion project at our client’s facility. The contractors will be responsible for the validation and qualification of new fill-finish equipment and filling lines to ensure compliance with GMP standards. The ideal candidates will have extensive experience in IQ (Installation Qualification) and OQ (Operational Qualification), as well as familiarity with commissioning activities. While PQ (Performance Qualification) experience is preferred, it is not mandatory. A background in GMP environments and Good Documentation Practices (GDP) is essential for these roles. Key Responsibilities •Validation & Qualification: Perform and support IQ/OQ for new fill-finish equipment and filling lines. Ensure that all equipment is installed and operating according to design specifications and regulatory standards. •Commissioning Support: Assist with the commissioning of new equipment, ensuring all systems and equipment function properly before starting the qualification process. •Documentation: Prepare, review, and maintain detailed validation protocols, reports, and documentation in alignment with Good Documentation Practices (GDP) and GMP regulations. •Collaboration: Work closely with cross-functional teams, including engineering, quality, and operations, to ensure seamless integration and validation of new systems. •Regulatory Compliance: Ensure that all validation activities meet GMP regulatory requirements, contributing to the safe and compliant operation of the facility. •Troubleshooting: Identify and resolve issues that arise during the validation process, collaborating with the team to ensure all equipment operates within validated parameters.   Qualifications •Experience: 4-10 years of hands-on experience in equipment validation and qualification, with a strong focus on IQ and OQ. Experience with PQ is preferred but not mandatory. •Industry Experience: Prior experience working in GMP-regulated environments is required, particularly in the pharmaceutical or biotech industries. •Equipment Knowledge: Experience with fill-finish equipment and filling lines is essential. Prior experience qualifying other types of equipment is a plus. •Commissioning Experience: Strong understanding of commissioning activities for new equipment and systems. •Documentation Skills: Proficiency in Good Documentation Practices (GDP), ensuring all validation activities are properly recorded and compliant with regulatory standards. •Ability to troubleshoot equipment and processes during the validation phase and effectively collaborate with technical teams to resolve issues. Preferred Qualifications: •Experience working with filling machines, sterile environments, and other fill-finish related systems. •Familiarity with FDA regulatory expectations related to equipment validation.

60 OPT placed StaffingALL has successfully placed over 60 international students with pharmaceutical and medical device clients through our preferred partner, ensuring their transition from OPT to securing an H1B visa. If you or someone you know (family or friends) has at least 6 months of experience in the pharmaceutical, medical device, or life sciences industries in roles such as QA, QC, batch record review, or similar, please send your resume to staffingalljobs@gmail.com. Our team will guide you through the entire process. Don’t miss this opportunity to advance your career! Comment opt if you’re on opt

Job Title: Batch Record Reviewer (Pharmaceuticals) Location: West Coast, USA (Multiple States) Employment Type: Full-Time Visa Status: Any visa accepted, H1B sponsorship available Job Overview: We are seeking an experienced Batch Record Reviewer with pharmaceutical experience to join our quality assurance team. This role involves reviewing batch records to ensure compliance with cGMP, FDA regulations, and internal quality standards. The ideal candidate will have a keen eye for detail and be able to work collaboratively with production teams to maintain accurate and complete documentation. Key Responsibilities: • Review batch records for accuracy, completeness, and compliance with cGMP, FDA regulations, and company standards. • Ensure all documentation is complete and meets regulatory requirements before product release. • Identify and report any discrepancies or deviations found in batch records, initiating corrective and preventive actions (CAPAs) when necessary. • Collaborate with production and quality teams to resolve documentation issues and ensure timely release of batches. • Maintain proper documentation and records for internal and external audits, ensuring audit readiness. • Provide input for continuous improvement of batch record review processes to increase efficiency and compliance. Requirements: • 1+ year of experience in batch record review or quality assurance in the pharmaceutical industry. • Strong understanding of cGMP, FDA regulations, and pharmaceutical manufacturing processes. • Excellent attention to detail, problem-solving, and organizational skills. • Ability to work both independently and collaboratively with cross-functional teams. • Familiarity with audit preparation and documentation is a plus. Location: • Multiple openings available across the West Coast (California, Washington, Oregon, and nearby states). Visa and Sponsorship: • Any visa is acceptable. • H1B sponsorship is available for qualified candidates. How to Apply: Please send your resume to staffingalljobs@gmail.com with the subject line “Batch Record Reviewer (West Coast) Application.”

Job Title: Batch Record Reviewer (Pharmaceuticals) Location: East Coast, USA (Multiple States) Employment Type: Full-Time Visa Status: Any visa accepted, H1B sponsorship available Job Overview: We are seeking an experienced Batch Record Reviewer with a background in the pharmaceutical industry to ensure that production records comply with regulatory standards and internal quality systems. The Batch Record Reviewer will be responsible for reviewing and approving batch records, ensuring that all documentation is accurate, complete, and in compliance with cGMP and FDA regulations. Key Responsibilities: • Review batch records for accuracy, completeness, and compliance with cGMP, FDA regulations, and internal SOPs. • Ensure that all production and quality control documentation is completed before product release. • Identify and report any discrepancies or deviations in batch records, initiating corrective and preventive actions (CAPAs) as necessary. • Work closely with production and quality teams to resolve issues related to batch record documentation. • Prepare and maintain records for internal and external audits, ensuring that all documentation is audit-ready. • Collaborate with cross-functional teams to drive continuous improvement in batch record review processes. • Ensure timely completion of batch record reviews to meet production schedules. Requirements: • 1+ year of experience in batch record review or quality assurance in the pharmaceutical industry. • Strong understanding of cGMP, FDA regulations, and quality documentation practices. • Excellent attention to detail, analytical, and organizational skills. • Ability to work collaboratively with production and quality teams to resolve documentation issues. • Proficiency in maintaining accurate records and preparing for audits. Location: • Multiple openings available across the East Coast (Maryland, Virginia, New Jersey, Delaware, and Washington DC). Visa and Sponsorship: • Any visa is acceptable. • H1B sponsorship is available for qualified candidates. How to Apply: Please send your resume to staffingalljobs@gmail.com with the subject line “Batch Record Reviewer (Pharmaceuticals) Application.”

Job Title: QA Engineer (Medical Devices) Location: East Coast, USA (Multiple States) Employment Type: Full-Time Visa Status: Any visa accepted, H1B sponsorship available Job Overview: We are seeking an experienced QA Engineer with a background in the medical device industry to ensure product quality and regulatory compliance. The QA Engineer will be responsible for managing quality assurance processes and ensuring that all medical device manufacturing and product development activities comply with FDA, ISO 13485, and other regulatory standards. The ideal candidate will have strong knowledge of medical device quality systems, risk management, and process validation. Key Responsibilities: • Develop and implement quality assurance processes and systems to ensure compliance with FDA, ISO 13485, and other regulatory standards for medical devices. • Lead process validation, equipment qualification, and risk management activities. • Perform root cause analysis and lead corrective and preventive actions (CAPAs) to resolve non-conformances and quality issues. • Manage the review and approval of design control documentation, including design verification and validation protocols. • Collaborate with engineering, manufacturing, and regulatory affairs teams to support product development and manufacturing processes. • Review and approve quality documentation, including non-conformance reports, batch records, and validation reports. • Participate in internal and external audits, ensuring that quality systems are compliant and audit-ready. • Drive continuous improvement initiatives in quality systems and product development processes. Requirements: • 2+ years of experience as a QA Engineer in the medical device industry. • Strong knowledge of FDA regulations, ISO 13485, and medical device quality systems. • Experience with process validation, design control, and risk management for medical devices. • Proven ability to manage CAPA processes and lead root cause analysis. • Excellent problem-solving, analytical, and communication skills. • Ability to work independently and in cross-functional teams. • Proficiency in quality management systems and documentation practices. Location: • Multiple openings available across the East Coast (Maryland, Virginia, New Jersey, Delaware, and Washington DC). Visa and Sponsorship: • Any visa is acceptable. • H1B sponsorship is available for qualified candidates. How to Apply: Please send your resume to staffingalljobs@gmail.com with the subject line “QA Engineer (Medical Devices) Application.”