Open Positions (16)

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CQV Project Lead – Facilities and Utilities

Wakefield , Massachusetts May 13, 2026 Life Sciences Position Overview: The CQV Project Lead – Facilities and Utilities is responsible for overseeing the commissioning, qualification, and validation (CQV) of facility infrastructure and utility systems critical to life sciences environments. This role ensures compliance with regulatory standards and internal quality requirements, focusing on systems essential for maintaining operational efficiency and product safety. Key Responsibilities: Lead CQV activities for facilities and utilities, including HVAC, VHP, clean utilities, and cold storage (refrigerators, freezers, walk-in cold rooms). Develop and execute protocols for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Collaborate with cross-functional teams to ensure smooth project delivery and regulatory compliance for facility spaces. Provide technical expertise for maintaining critical environmental and storage conditions. Required Qualifications: Bachelor’s degree in Life Sciences, Engineering, or related field. 5+ years of experience in facilities/utilities CQV within life sciences. Knowledge of HVAC systems, cleanroom validation, and regulatory requirements for facilities and utilities.

CQV Project Lead – Manufacturing Systems

Wakefield , Massachusetts May 13, 2026 Life Sciences Position Overview: As a CQV Project Lead for Manufacturing Systems, you will oversee the commissioning, qualification, and validation (CQV) of life sciences manufacturing equipment and environments. Your role ensures that all manufacturing suites and equipment meet regulatory standards, focusing on maintaining product integrity and process reliability. Key Responsibilities: Lead CQV efforts for manufacturing systems including HVAC, BSCs, LFHs, autoclaves, parts washers, and single-use equipment (mixers, bioreactors). Execute CQV protocols for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure validation of laboratory equipment (bench scales, pH meters, Vi-Cell analyzers) to support manufacturing processes. Work closely with cross-functional teams to integrate CQV processes into daily manufacturing operations. Required Qualifications: Bachelor’s degree in Life Sciences, Engineering, or related field. 5+ years of experience in manufacturing CQV

Compliance Specialist – Validation Support

Wakefield , Massachusetts May 13, 2026 Life Sciences Position Overview: The Compliance Specialist – Validation Support assists with audit readiness, validation documentation, and compliance improvement initiatives. This role ensures that validation processes and quality systems adhere to regulatory standards, supporting internal and external audits to maintain compliance. Key Responsibilities: Collaborate with validation and quality management teams during audits, preparing and organizing validation documentation. Lead deviation, CAPA, and change control processes for validation, supporting root cause analysis and resolution. Schedule and facilitate post-validation lessons learned sessions to improve future project outcomes. Track metrics related to validation activities, including requalification and periodic reviews, to support continuous improvement. Required Qualifications: Bachelor’s degree in Life Sciences, Quality Assurance, or a related field. 5+ years of experience in compliance and validation within regulated industries.

Computer System Validation (CSV) Engineer

Wakefield , Massachusetts May 13, 2026 Life Sciences Position Overview: The Computer System Validation (CSV) Engineer is responsible for the validation of computerized systems and infrastructure within regulated environments. This role involves developing and executing validation protocols to ensure compliance with 21 CFR Part-11, Annex-11, and other regulatory standards. Key Responsibilities: Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices. Manage and update validation activities, ensuring alignment with day-to-day operations and project work. Review and provide feedback on System Delivery Life Cycle (SDLC) documents, ensuring adherence to Standard Operating Procedures (SOPs). Author and update SOPs, templates, and related documentation to support ongoing CSV compliance. Required Qualifications: Bachelor’s degree in Computer Science, Life Sciences, or related field. 5+ years of experience in computer system validation within life sciences.

QC Microbiology Specialist

Wakefield , Massachusetts May 13, 2026 Life Sciences Position Overview: The QC Microbiology Specialist plays a crucial role in quality control, focusing on microbiological testing, aseptic processing, and environmental monitoring. This position supports quality improvement and compliance within a sterile manufacturing environment. Key Responsibilities: Oversee the management of MODA-EM and LIMS systems, ensuring accurate test configurations and user requirements. Develop and implement trending programs, environmental monitoring protocols, and aseptic process simulations. Conduct microbial testing, deviation investigations, and CAPA processes to resolve quality issues. Monitor and analyze environmental and utility monitoring data, setting alert and action limits for compliance. Required Qualifications: Bachelor’s degree in Microbiology, Life Sciences, or a related field. 5+ years of experience in QC microbiology within sterile manufacturing. Knowledge of regulatory guidance (FDA, EU, JP)

FPGA Engineer

Wakefield , Massachusetts May 13, 2026 SW/HW Engineering Position Overview: We are seeking a skilled FPGA Engineer with expertise in designing and testing FPGA systems. This role focuses on developing FPGA solutions for embedded systems, emphasizing VHDL and the Xilinx Zynq platform. The ideal candidate will approach both design and verification processes hands-on to deliver high-performance, reliable solutions. Key Responsibilities: Develop FPGA designs for embedded systems, ensuring they meet project specifications. Conduct comprehensive testing and debugging of FPGA designs to verify functionality. Program and configure FPGAs using VHDL, specifically for Xilinx Zynq platforms. Collaborate with cross-functional engineering teams to ensure project requirements and performance standards are met. Document design, testing, and debugging processes to ensure compliance. Required Qualifications: 5+ years of experience in FPGA design and testing, with a focus on VHDL.

Embedded Software Engineer

Wakefield , Massachusetts May 13, 2026 SW/HW Engineering Position Overview: We are looking for an Embedded Software Engineer to develop software for real-time embedded systems. This role involves C/C++ programming within VxWorks or Linux RTOS environments, with a focus on Object-Oriented Design (OOD) principles. Familiarity with RF systems, including RF EW, and experience with version control tools like ClearCase, ClearQuest, and Git/GitHub is preferred. Key Responsibilities: Develop embedded software applications using C/C++ in VxWorks or Linux RTOS. Use Object-Oriented Design principles to optimize software architecture. Integrate software with hardware to ensure compatibility and functionality. Manage code changes with version control tools (ClearCase, ClearQuest, Git/GitHub). Collaborate on RF system integrations, ideally including RF EW systems. Conduct software testing and debugging to ensure reliability. Required Qualifications: Bachelor’s degree in Electrical Engineering, Computer

Embedded Firmware Engineer

Wakefield , Massachusetts May 13, 2026 SW/HW Engineering Position Overview: We are seeking an Embedded Firmware Engineer to develop firmware for embedded systems, focusing on ARM architecture. This role requires expertise in Embedded C programming, experience with SoC platforms like Xilinx Ultrascale+ or Zynq, and interfacing with FPGAs. Key Responsibilities: Develop firmware using C programming for ARM architecture. Work with SoC platforms (Xilinx Ultrascale+, Zynq) to develop and test firmware. Interface and integrate firmware with FPGAs, ensuring system functionality. Design and implement communication protocols for devices on SPI, I2C, and other busses. Document firmware design for maintainability and quality. Required Qualifications: Proficiency in Embedded C programming for ARM. 5+ years of experience in embedded firmware engineering. Experience with SoC platforms (Xilinx

ASIC Design/Verification Engineer

Wakefield , Massachusetts May 13, 2026 SW/HW Engineering Position Overview: We are looking for an experienced ASIC Design/Verification Engineer with extensive expertise in design verification. Proficiency in HDL (VHDL/Verilog) and HVL (SystemVerilog), along with experience in SystemVerilog Assertions (SVA) and UVM, is essential. Key Responsibilities: Verify ASIC designs using VHDL/Verilog and SystemVerilog with coverage-driven methodologies. Implement SystemVerilog Assertions (SVA) and use UVM for thorough verification. Develop and monitor verification plans, refining strategies as necessary. Use scripting (Tcl, Python, Perl) to streamline verification workflows. Collaborate with design engineers to debug and ensure quality. Required Qualifications: 9+ years of experience in ASIC verification. Expertise in HDL and HVL languages, SystemVerilog Assertions, and UVM. Knowledge of industry-standard interfaces. Preferred

Test Engineer

Wakefield , Massachusetts May 13, 2026 SW/HW Engineering Position Overview: We are seeking a Test Engineer with expertise in LabVIEW and TestStand for designing and executing automated test solutions. This role requires strong instrumentation skills, National Instruments platform experience, and preferably NI certification. Key Responsibilities: Develop and maintain automated test scripts with LabVIEW and TestStand. Conduct software and hardware testing to verify product quality. Set up, calibrate, and maintain test equipment for accurate data collection. Troubleshoot and resolve issues in testing systems. Document and report test results to relevant teams. Required Qualifications: 5+ years of experience in test engineering, with a focus on LabVIEW and TestStand. Strong background in instrumentation and test setup. National Instruments certification preferred.