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COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills,…
Project Manager leading cross-functional pharmaceutical R&D programs from preclinical research through clinical development at Syner-G in San Diego. Coordinates scientific, clinical, regulatory, quality, and operational stakeholders, driving planning, budgets, risk management, and regulatory submission support using tools like Microsoft Project and Smartsheet.
Leads biopharma clients through operational excellence programs, deploying Lean Six Sigma and change management to drive sustainable transformation and measurable improvements in quality, cost, and delivery.
Oversee construction and engineering projects for biopharma facilities, coordinating contractors, schedules, budgets, and compliance from planning through commissioning.
Senior engineer designs, builds, and qualifies aseptic fill–finish suites for biologic drugs, ensuring GMP compliance and smooth commercial launch.
Coordinates construction and maintenance projects in biopharma facilities, ensuring safety compliance and smooth execution while managing documentation and stakeholder communication.
Leads complex construction and engineering projects in biopharma facilities, coordinating contractors, ensuring safety and regulatory compliance, and delivering projects on time and budget.
Validation Engineer at a biopharma consultancy in Boston, writing and executing protocols (FAT, SAT, IOQ, PQ) to qualify equipment, utilities, and processes for FDA cGMP compliance.
Oversee large biotech construction projects from design through commissioning, ensuring cGMP compliance and safe execution while coordinating contractors and equipment logistics.
Designs and implements terminal sterilization programs for biopharma clients, ensuring product safety and regulatory compliance while collaborating with cross-functional teams.
The Senior Validation Engineer leads validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments, developing and executing validation lifecycle documentation while ensuring compliance with regulatory expectations.
Regulatory consultant reviews and approves promotional materials for prescription drugs in the US and Canada, ensuring compliance with FDA, OPDP, Health Canada, and PAAB standards.
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