The Sr. Validation Engineer will lead validation activities for equipment, utilities, and computerized systems within GMP-regulated environments. They are responsible for developing validation documentation, providing technical mentorship, and ensuring compliance with regulatory standards.
The Sr. Fill-Finish Process Engineer will support the design, construction, and qualification of a new commercial fill-finish suite while serving as a subject matter expert for aseptic manufacturing processes. They will collaborate with cross-functional teams to troubleshoot technical issues, ensure regulatory compliance, and manage engineering lifecycle documentation.
The Senior Project Manager will lead strategic client initiatives and complex capital projects while establishing project governance and portfolio management practices. This role involves driving project execution, ensuring stakeholder alignment, and acting as a trusted advisor to client leadership.
The Senior Talent Acquisition Specialist manages the full recruitment lifecycle for India-based roles while partnering with leadership to execute strategic hiring initiatives. They are responsible for building talent pipelines, improving recruitment processes, and serving as a trusted advisor on market trends and compensation.
The Reliability Engineer will support maintenance and asset management activities within regulated pharmaceutical or biotechnology manufacturing environments. They will collaborate cross-functionally to optimize preventive maintenance strategies, reduce unplanned downtime, and improve overall equipment reliability.
The Senior Program Manager serves as a strategic partner to executive leadership, driving alignment and operational excellence across critical product development initiatives. This role involves establishing governance structures, managing cross-functional portfolios, and facilitating executive decision-making to ensure strategic objectives are met.
The Senior Program Manager will provide strategic leadership and execution oversight for complex product development initiatives across the life sciences portfolio. This role involves coordinating cross-functional teams, managing program governance, and ensuring alignment from concept through commercialization.
The Senior Reliability Engineer will lead reliability assessments, root cause investigations, and maintenance strategy development for critical facility infrastructure. This role involves optimizing CMMS processes and partnering with cross-functional teams to improve asset performance and reduce unplanned downtime.
The CMMS Administrator is responsible for maintaining and supporting the site's Computerized Maintenance Management System, including data accuracy, work order management, and equipment records. They also manage service contracts, inventory, and department training records while providing reporting and metrics to leadership.
The Consultant II leads the regulatory review and risk assessment of promotional materials to ensure compliance with FDA, Health Canada, and PAAB standards. They serve as a key partner to cross-functional teams to facilitate the compliant execution of brand strategies across various platforms.
The Documentation Management Lead will oversee project documentation, information management, and document workflows across engineering and construction workstreams. They will serve as the primary point of contact for project controls and site services to ensure all project information is accurate and accessible throughout the lifecycle.
The Project Manager guides clients through the development and execution of comprehensive Operational and Business Excellence programs. This role serves as a strategic partner to client leadership to drive sustainable transformation and continuous improvement.
The Facilities Technician II is responsible for the day-to-day support, maintenance, and inspection of building operations, lab equipment, and manufacturing utilities. They must ensure all maintenance tasks are documented according to GMP standards and respond to facility emergencies as needed.
The Sr. Validation Engineer will lead validation activities for equipment, utilities, and computerized systems within GMP-regulated environments. They are responsible for authoring and executing validation documentation while providing technical mentorship to junior staff.
Lead validation activities for equipment, utilities, facilities, and computerized systems within GMP-regulated environments. Oversee the generation and execution of validation lifecycle documentation while providing technical mentorship to junior staff.
The Sr. Process Engineer will develop and implement a comprehensive terminal sterilization program, including defining cycle parameters and sterilization architecture. They will collaborate with cross-functional teams to support commissioning, qualification, and validation activities while ensuring regulatory compliance.
Lead the continuous improvement of enterprise applications and data platforms through business analysis, system administration, and governance. Develop reporting solutions and manage data integrations across platforms like Salesforce, NetSuite, and Power BI.
Act as the owner's representative for large, complex construction projects in lab or cGMP manufacturing environments. Manage the full project lifecycle from design through construction and commissioning, including supervising sub-contractors and managing building systems.
Lead a portfolio of approximately 10 concurrent mAb drug substance technology transfer programs from process handoff through GMP manufacturing and PPQ. Establish governance, resource planning, and risk mitigation strategies to ensure technical readiness and commercialization success.
Lead the expansion of biologics delivery capabilities on the West Coast by driving client development and market credibility. Personally execute biologics CMC consulting engagements and provide expert guidance across the program lifecycle from development to regulatory submission.
Lead the planning and execution of integrated Verification and Commissioning & Qualification (C&Q) programs for large-scale GMP-regulated capital projects. Manage the full project lifecycle from design through operational handover, ensuring compliance with ASTM E2500 principles.
Author and manage regulatory documents such as Clinical Study Reports and protocols while leading document development efforts. Serve as a project owner by coordinating timelines and collaborating with cross-functional teams to ensure submission readiness.
The Validation Engineer is responsible for developing and executing validation protocols (FAT, SAT, IOQ, PQ) for processes, equipment, and facilities. They drive overall quality performance and compliance by maintaining the organization's validation program and supporting tech transfer projects.
Design and develop stable formulations for high concentration subcutaneous dosage forms and optimize lyophilization processes. Manage the transfer of designs to CDMO partners and prepare regulatory submissions such as INDs and CTAs.
Oversee the design, validation, and execution of analytical methods for oligonucleotides and peptides while managing transfers to CDMO partners. Collaborate with CMC teams to prepare regulatory submissions and ensure compliance with FDA, EMA, and ICH guidelines.
Provide advanced organizational and administrative support for construction and maintenance projects with a heavy focus on health and safety. Act as a facilitator between project managers, contractors, and stakeholders to ensure regulatory compliance and efficient project execution.
The role involves guiding clients through regulatory affairs, overseeing the preparation and submission of clinical and non-clinical documents to the FDA. Additionally, it entails leading the implementation of digital validation platforms like ValGenesis or Kneat within regulated pharmaceutical environments.
The Vice President of Regulatory Partnerships will lead and expand strategic regulatory partnerships with a focus on post-approval lifecycle management and integrated client solutions. This role involves driving revenue growth, managing global teams, and ensuring operational excellence across regulatory consulting and service lines.
The Sr. Fill-Finish Process Engineer will support the design, construction, and qualification of new commercial fill-finish suites while serving as a subject matter expert for aseptic manufacturing processes. They will collaborate with cross-functional teams to ensure technical troubleshooting, process optimization, and strict adherence to GMP and regulatory standards.
The Senior Process Engineer will lead process optimization for oral solid dose manufacturing and support technology transfer activities. They will troubleshoot complex process issues and collaborate with various teams to implement sustainable process improvements.
The Facilities Technician III is responsible for performing advanced maintenance activities and troubleshooting complex issues across multiple building systems. This role also includes supporting reliability and compliance requirements in laboratory, manufacturing, and utility environments.
This role involves leading the strategic planning, development, and execution of the company’s AI roadmap and long-term innovation strategy, focusing on identifying and prioritizing opportunities to improve operations and business value. Key functions include overseeing the entire AI development lifecycle, implementing responsible AI frameworks, building and mentoring a high-performing AI organization, and communicating complex technical insights to executive leadership.
