Senior Engineer, GxP

DescriptionLooking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.Your Role:The Senior Engineer, GxP is responsible for the technical design, planning, implementation, and support of enterprise systems and laboratory equipment to ensure that these are operating at optimum levels. They will serve as the technical expert in systems administration for specialized manufacturing, development, and quality control systems and recommends the redesign, configuration, recovery, and continuity plans of the operational and information technology and applications for these systems. They analyze the feasibility of system requirements and develops system specifications and will support project leadership and management in the identification, development, and adoption of technology and processes to deliver quality reliable solutions in the support of our core manufacturing and quality control operations. Maintain system administration documentation for various laboratory instruments, enterprise systems, and manufacturing equipment. Support the generation andor modification of test methods for various laboratory equipment. Provide technical and documentation support for the change management process on the supported systems and equipment. Performs equipment testing as needed. Trains technical staff in the operation of developed andor acquired software and hardware. Provides tools, procedures, and training sessions for Operations, Support and Systems Development staff who assist in support efforts. Provide guidance or work instructions to internal and external users. Performs troubleshooting and supports problem-solving efforts with vendors. Supports security policies and procedures to protect systems from unauthorized or unintended use andor abuse. Coordinates and supports project efforts to maximize benefits and minimize impact to departments and operations. Other tasks as assigned.Minimum Qualifications: Bachelor's degree in Life Sciences, Computer Science, or related disciplines. Relevant experience may substitute for the degree requirement on a year for year basis. 1+ years' work experience in technical writing, complex systems design, and support. Experience using: Spectramax M2M3 plate readers, Agilent 11001200 HPLCS, BioTek plate readers, Beckman DU800, Beckman HPLC (planned retirement), Beckman PA800Plus instruments and Softmax Pro GxP, OpenLab and Empower 3, Endoscan V, DU800 UVVis, and 32 Karat software is preferred. Ability to establish and maintain cooperation, understanding, trust, and credibility. Ability to plan, organize, and document complex system design activities and to configure systems to be consistent with organization's policiesprocedures Ability to communicate technicalcomplex information verbally and in writing. Ability to perform tasks timely and efficiently and respond to emergency situations effectively as needed.Physical demandsrole specific needs:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with different abilities to perform the essential functions. Occasional exposure to risk of electrical shock Occasional exposure to toxic or caustic chemicals Occasional exposure to vibration Occasional exposure to fumes or airborne particles Occasional exposure to wet or humid conditions (non-weather) Occasional work near moving mechanical parts Noise level in the work environment is occasionally loudWork Environment: Regular requirement to sit, talk or hear, use hands to finger, handle or feel, or reach with hands and arms. Frequent requirement to stand and walk. Occasional requirement to climb or balance, stoop, kneel, crouch, or crawl. Regularly lift up to 10 pounds. Occasionally lift up to 20 pounds. Specific vision abilities required include close vision, distance vision, and color vision.Who you are: You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. Your written and verbal skills are out of this world, and you communicate with clarity and confidence. You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or pensation:We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $97,000-$129,400 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Created: 2025-02-23