BTS Senior Engineer, Technology I

Description

The role covers the full lifecycle of digital software life cycle controls, from design and implementation through evidence collection, continuous monitoring and inspection readiness. It is not a software testing or QA engineering role. It sits between regulatory compliance and technology functions, handling IT governance with current tooling.

The position suits a quality and compliance professional who understands how CI/CD pipelines, source control, test management tools and artifact repositories work, and who uses that knowledge to put regulatory expectations into automated controls. You will translate between governance stakeholders and the engineers who build and maintain these tools.

Responsibilities

• Design, implement, maintain and keep improving the software life cycle framework across technology systems and platforms, taking a patient-centric, risk-based approach in line with GAMP principles.
• Find ways to automate collecting, validating and reporting IT control evidence inside CI/CD pipelines and connected toolchains. Favour electronic evidence over paper, in line with FDA and industry CSA guidance.
• Use AI tools to improve control monitoring, trend analysis and anomaly detection on regulated systems. Assess the compliance and data integrity risks of self-learning systems and set governance for them.
• Act as the link between compliance and technology teams, turning governance and regulatory requirements into terms that the engineers configuring tools and designing pipelines can act on.
• Work directly with the teams running Jira, GitHub, JFrog, qTest, ServiceNow and similar platforms. Build controls into the source so these tools produce correct evidence in the correct format.
• Own digital traceability records that link requirements, controls, system design elements and verification evidence. Keep them live and dynamic so they can be audited at any time, not static or paper-based.
• Apply ALCOA+ principles and data lifecycle controls to build data integrity into every governed system.
• Prepare audit and inspection evidence, lead remediation, and make sure the team can answer regulator questions with real-time digital records.
• Report interdependencies and control status to governance stakeholders and leadership, explaining technical detail in compliance terms.
• Help develop the controls assurance method by applying Validation 4.0 principles: quality by design, data integrity by design and integrated environments, as technology and regulatory expectations evolve.

Requirements

• A bachelor's degree with 6 years of relevant experience, a master's degree with 5 years, or a PhD with 0 years.
• Proven experience working in a regulated industry such as pharmaceuticals, medical devices or a similar field.
• Working knowledge of modern development toolchains, such as GitHub, Jira, JFrog Artifactory, qTest, ServiceNow CMDB and/or CI/CD platforms like Azure DevOps or AWS CodePipeline.
• Ability to convert regulatory requirements into technical specifications, acceptance criteria and control configurations.
• Experience building controls into DevOps workflows or software delivery pipelines.
• Able to communicate credibly with both governance stakeholders and engineering teams.
• Ability to learn quickly and work in a fast-moving environment.
• Optional: familiarity with AI systems in a regulated setting, including governance, validation and data integrity considerations, is a plus.

Conditions

Pay disclosure applies in locations covered by state or local law. The base pay range is the company's good-faith estimate for this grade at posting. Actual pay within the range depends on factors including geographic location, and may fall above or below it. The range may change.

Eligible for the company's short-term incentive programs.

Bonuses, incentives and other compensation are not earned or owed until paid. The company may change them at its sole discretion, consistent with applicable law.

The company is an equal opportunity employer. Open to US and Puerto Rico applicants only.

Benefits

• Paid time off covering vacation, holidays and sick leave.
• Medical, dental and vision insurance, plus a 401(k) for eligible employees.