Sr. Engineer, GxP Systems

Jobvite, Inc.; Tustin (CA); On-site; USD 94,000 - 117,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices is seeking a Senior Engineer, GxP Systems to lead technical design, planning, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation in a GMP environment. You’ll collaborate with project teams to implement technology solutions that align with regulatory expectations.

The role requires 5–7 years in complex systems in GMP settings, and hands-on experience with Empower 3, DeltaV, and other regulated platforms.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or related field.
• 5–7 years of experience in complex systems design, systems administration, application support, or regulated equipment support in GMP environments.
• Hands-on experience with regulated lab/manufacturing platforms (Empower 3, DeltaV, Rockwell FactoryTalk, Cytiva UNICORN, Sartorius MFCS/BioBrain, Sartocheck 4/5).
• Knowledge of 21 CFR Part 11, GAMP 5, ALCOA+ data integrity concepts.
• Experience leading projects and mentoring junior engineers.
• Ability to communicate complex technical information to technical and non-technical audiences.

Responsibilities

• Lead system administration documentation for laboratory instruments, enterprise systems, and manufacturing equipment.
• Develop, review, and update design specifications, procedures, and support documentation for GMP equipment and processes.
• Support test methods and system testing activities for laboratory and manufacturing equipment.
• Provide technical guidance and documentation support for change control, deviations, CAPAs, upgrades, and lifecycle management.
• Train staff on software/hardware and coordinate with cross-functional teams.
• Lead complex troubleshooting, coordinate vendor engagement, and drive corrective actions for regulated systems.
• Support security policies and access controls for OT environments.
• Coordinate project activities to maximize value and minimize operational impact.

Skills

GxP systems

Regulatory compliance

Technical documentation

Project leadership

Communication

Education

Bachelor's degree in Life Sciences / IT / Engineering

Tools

Empower 3

Emerson DeltaV

DeltaV Mobile

Rockwell FactoryTalk

Cytiva UNICORN

Sartorius MFCS/BioBrain

Sartocheck 4/5

Job description

Looking 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. The Senior Engineer, GxP Systems leads the technical design, planning, implementation, administration, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation within a GMP‑regulated environment. This role serves as a technical expert for specialized manufacturing, process development, and quality control systems, ensuring platforms operate reliably, securely, and in alignment with applicable policies, procedures, and regulatory expectations. Working with a high degree of independence, the Senior Engineer, OT evaluates system requirements, develops system specifications, and supports recovery and continuity planning. The role partners with project leadership to identify and implement technology and process improvements that support core manufacturing and quality control operations.

Key Responsibilities:

• Lead and maintain system administration documentation for laboratory instruments, enterprise systems, manufacturing equipment, and regulated applications to support reliable, compliant operations.
• Develop, review, and update design specifications, work instructions, technical procedures, and support documentation for GMP equipment, systems, and processes.
• Support the development, modification, and execution of test methods and system testing activities for laboratory and manufacturing equipment.
• Provide technical and documentation support for change management, deviation investigations, corrective actions, system upgrades, and lifecycle management activities.
• Perform equipment and application testing and train technical staff on developed, upgraded, or acquired software and hardware.
• Provide technical guidance, procedures, and training to Operations, Support, Systems Development, vendors, and cross‑functional project teams.
• Lead complex troubleshooting, coordinate vendor engagement, and drive problem resolution for regulated systems and equipment.
• Support security policies, access controls, and procedures designed to protect systems from unauthorized or unintended use.
• Coordinate and support project activities to maximize business value, minimize operational impact, and enable successful implementation of technology solutions.

Minimum Qualifications:

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or a related discipline; relevant experience may substitute for the degree requirement on a year-for-year basis.
• 5 to 7 years of relevant experience in complex systems design, systems administration, application support, technical documentation, or regulated equipment support, including experience in a GMP-regulated manufacturing or laboratory environment.
• Hands‑on experience with a combination of regulated laboratory and manufacturing platforms such as Empower 3, Emerson DeltaV and DeltaV Mobile, Rockwell FactoryTalk, Cytiva UNICORN, Sartorius MFCS/BioBrain, Sartocheck 4 and 5, or equivalent systems.
• Working knowledge of 21 CFR Part 11, GAMP 5, and data integrity principles, including ALCOA+.
• Ability to plan, organize, document, and execute complex system design and support activities in alignment with organizational policies, procedures, and compliance expectations.
• Experience leading projects and mentoring junior engineers.
• Ability to communicate complex technical information clearly to technical and non‑technical audiences.
• Ability to prioritize competing demands and respond effectively to emergency or production‑impacting situations.

Preferred Qualifications:

• Experience with Computer System Validation activities, including IQ/OQ/PQ authoring and execution.
• Experience with SpectraMax SoftMax Pro, Agilent HPLC, BioTek plate readers, EndoScan‑V, Beckman PA800/Plus, Versa Star Pro pH Meter, Endosafe, DU800 UV/Vis, BMRAM, or equivalent systems.
• Familiarity with backup, disaster recovery, and business continuity practices for regulated systems, including Veeam, Acronis, or equivalent tools.
• Exposure to cybersecurity frameworks relevant to OT environments, such as NIST 800-82 or IEC 62443.
• Experience supporting client or regulatory audits and working within a matrixed IT, Engineering, and Quality organization.

Position Type/Expected Hours of Work:

This role is a full‑time onsite position. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours as needed. This position includes participation in an on‑call rotation to provide support outside of regular business hours.

Compensation:

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 $93,600 to $117,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

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 suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day‑to‑day demands of this position.