AHU Technologies: GxP Instrument Systems Engineer- Norwood, MA

Job Overview

AHU Technologies is actively seeking a GxP Instrument Systems Engineer (Senior Project Engineer) based primarily in Norwood, MA. This position, while located at the company headquarters, allows for remote work from anywhere in the United States, making it an attractive opportunity for professionals in the field. The company boasts a commitment to rapid response times regarding job inquiries, with replies promised within 24 hours.

Role Responsibilities

The selected candidate will be tasked with several vital responsibilities that play a critical role in the automation and management of digital enterprise instrumentation systems. These systems are essential in supporting Quality Control laboratories, requiring the engineer to:

Collaborate with both Business Analysts and Software/Automation Engineers throughout the full product lifecycle management of various Digital Quality Automation Systems such as Hamilton Venus, Waters Andrew+ with OneLab, and more.
Manage the design, deployment, and maintenance of Enterprise Instrumentation Systems, specifically systems related to chromatographic data and scientific data management. This includes ensuring regular updates and version upgrades are executed smoothly.
Translate data integration and system requirements derived from various teams into feasible solutions, enhancing laboratory operations.
Oversee change control for regulatory digital documentation including Standard Operating Procedures (SOPs) and work instructions, crucial for compliance with industry regulations.
Partner with stakeholders to successfully validate and integrate systems crucial to the future of instrumentation, robotics, and automation initiatives.
Identify process optimization opportunities and implement upgraded solutions to enhance operational efficiency.
Ensure compliance with Good Manufacturing Practice (GMP) throughout all phases of the project from design to delivery and maintenance.
Maintain readiness for inspections and actively participate in both internal and external audits as required.

Required Qualifications

To be considered for this critical position, candidates must possess the following qualifications:

A Bachelor’s degree or equivalent in a relevant field of study such as science, engineering, or computer science.
A minimum of 5 to 7 years of experience in designing, implementing, and managing life sciences enterprise systems within a biopharmaceutical GMP environment.
Direct experience with automation solutions, particularly Hamilton Venus.
Familiarity with advanced automated laboratory analytical systems, such as Waters Andrew+, Hamilton Venus liquid handlers, and others.
Knowledge of GxP compliance regulations, GAMP criteria, and data integrity standards, alongside a strong grasp of connectivity between on-premise systems and cloud-hosted digital systems.
Proven ability to work effectively in both independent and team environments, showcasing strong communication skills essential for cross-functional collaboration.
Demonstrated capacity to manage multiple projects concurrently in a fast-paced setting, reflecting robust relationship-building skills.

Contract Type

This role is classified as a full-time position, allowing candidates to dive deeply into their work with the stabilizing benefits of a permanent role while also offering the flexibility of a remote setup.

Company Overview

AHU Technologies INC. is an IT consulting and permanent staffing firm that has gained recognition for its commitment to addressing the evolving technology needs of prominent corporations across the United States. Since its inception, the firm has remained at the forefront of providing tailored IT solutions that help businesses reduce operational costs and enhance resource allocation towards strategic initiatives.

The organization is co-founded by forward-thinking techno-commercial entrepreneurs and employs numerous highly skilled independent consultants, enabling the firm to adapt and respond swiftly to a wide variety of client needs. Their service offerings extend to projects focused on media, telecommunications, data warehousing, web applications, and ERP solutions, showing their broad expertise and adaptability in various industries.

Location

The position will require on-site presence 3-4 days a week at locations in or around Marlborough, MA and Norwood, MA. Therefore, commuting to these locations is essential for candidates who live outside those areas but seeking a remote work opportunity balanced with required on-site collaboration.

Career Opportunities

For job seekers interested in combining their passion for technology and quality improvement in the life sciences sector, this position presents an excellent opportunity at the intersection of digital innovation and regulatory compliance. Ideal for those with a robust background in life sciences and a desire to contribute towards advancing laboratory automation and efficiencies, candidates are encouraged to apply for this role to further their careers at AHU Technologies.

This job offer was originally published on weworkremotely.com