Sr MasterControl Systems Engineer

YOUR ROLE: The Senior MasterControl Systems Engineer is responsible for independently configuring, integrating, and maintaining MasterControl within a team setting to support both quality management and manufacturing processes. This role ensures that quality records, compliance workflows, and production data flow smoothly across systems, improving efficiency and traceability; partners closely with QA/RA, IT, and Operations to manage system modules, optimize integrations, and deliver solutions that are audit-ready and compliant with regulatory standards; demonstrates Promega's values through collaboration, accountability, and adaptability in a dynamic environment.
 
CORE DUTIES:
 
1. Module Configuration & Support: Configure and operate Qx (Document Control, Change Control, Training, Audit, Risk, and Quality Event Management) and Mx (electronic batch records, digital work instructions, recipe/variant authoring).
 
2. API Integration: Build/support data exchanges using MasterControl's API Toolkit (authentication, endpoints, payloads, throttling, and error handling). Operate within or near industry standard integration middleware.
 
3. Two-Way System Flows: Help implement triggers/actions between MasterControl and enterprise systems such as ERP (business operations), LIMS (lab testing), MES (manufacturing), CRM (customer interactions), and PDM (product design) so that quality events, production data, and customer feedback are automatically linked. Ensure data alignment and record reconciliation.
 
4. Dashboarding & Reporting: Maintain dashboards using MasterControl Insights; support downstream embedding and access management (Viewer/Author roles).
 
5. SSO & Access: Configure and troubleshoot SAML-based SSO (IdP/SP metadata, claims, and certs), especially in Microsoft Entra ID environments.
 
6. Validation & Release Support: Execute validation deliverables (IQ/OQ/PQ); support release cycles using MasterControl validation accelerators. Understand 21 CFR Part 11 and EU Annex 11 expectations.
 
7. Troubleshooting & Support: Investigate issues across stack (MasterControl, middleware, connected systems). Assist with change control, rollback, and documentation processes.
 
8. Training & Rollout Support: Support end-user onboarding, build reports/metrics, and assist with rollout and adoption of MasterControl solutions.
 
9. Develop and support technical solutions that align with team and organizational goals.
 
10. Work independently to complete assigned tasks, while collaborating closely with team members.
 
11. Demonstrate clear and respectful communication with technical and non-technical stakeholders.
 
12. Manage time effectively to meet deadlines and prioritize work.
 
13. Adapt to changes in priorities, workflows, and technologies with resilience.
 
14. Share knowledge and support peer learning within the team.
 
15. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
 
16. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.
 
17. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
 
KEY QUALIFICATIONS:
 
1. Associate degree or equivalent work experience.
 
2. 5–7 years of relevant experience in an engineering or technical role.
 
3. Proficiency in configuring MasterControl Qx modules with roles, workflows, routes, and audit trails.
 
4. Familiarity with Mx elements like digital work instructions, EBR/eDHR content, and training enforcement.
 
5. Working knowledge of API integrations and post-deployment troubleshooting.
 
6. Hands-on experience with SSO and access control in regulated environments.
 
7. Demonstrated ability to support validation activities and operational documentation.
 
8. Proven ability to manage tasks independently while contributing to a team.
 
9. Strong interpersonal and communication skills.
 
10. Proficient in operating a computer and phone, using Microsoft Office applications, and adapting to emerging technologies relevant to the role.
 
PREFERRED QUALIFICATIONS:

1. Experience with MasterControl's API Toolkit, XML/JSON payloads, and Postman or similar tools.
 
2. SQL proficiency for reporting joins and light scripting in Python or PowerShell.
 
3. Exposure to SAP ERP, LIMS, MES, CRM, or PDM systems.
 
4. Experience working in collaborative, cross-functional environments.
 
5. Demonstrated openness to feedback and growth.
 
6. Familiarity with project tracking or task management tools.
 
PHYSICAL DEMANDS:
 
1. Ability to remain stationary for several hours at a time.
 
2. Ability to use a computer/Microsoft Office applications.

At Promega, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.