mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its services include theassessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensiveproject management supportto ensure compliance, efficiency, and operational excellence.
Position Summary The Senior Engineer provides technical leadership and engineering support for manufacturing operations. This role is responsible for ensuring that engineering activities related to production processes, facilities, and equipment are executed in compliance with cGMP requirements, company standards, and regulatory expectations. The Senior Engineer works independently on complex assignments, supports cross-functional initiatives, and contributes to continuous improvement, validation, and change management activities across operations.
Key Responsibilities
Provide engineering support to pharmaceutical/biotech manufacturing operations, ensuring compliance with cGMP procedures and engineering best practices.
Author, review, and approve technical documentation, including engineering reports, protocols, procedures, and specifications.
Lead and support Change Control, Quality Risk Assessments (QRAES), nonconformance investigations, and CAPA activities.
Support equipment, facility, and process validation activities in accordance with regulatory and internal requirements.
Work with computerized systems such as Maximo to support asset management, maintenance activities, and work order execution.
Prepare, review, and submit Purchase Orders (POs) as required to support engineering and operational needs.
Coordinate, manage, and escort external vendors and contractors performing work on-site.
Manage multiple projects, tasks, and priorities simultaneously while ensuring quality, timeliness, and compliance.
Collaborate effectively with Manufacturing, Quality, Maintenance, Validation, and other cross-functional teams.
Provide technical expertise and after-hours engineering support as needed to ensure continuity of 24/7 operations.
Promote a culture of safety, quality, compliance, and continuous improvement.
Education & Experience Requirements One of the following education and experience combinations is required:
Doctorate degree OR
Master’s degree with 2 years of Engineering experience OR
Bachelor’s degree in Engineering with 4 years of Engineering experience
Required Skills & Qualifications
Excellent written and verbal communication skills.
Strong technical writing experience.
Working knowledge and hands-on experience with cGMP procedures and engineering practices in pharmaceutical or biotechnology manufacturing environments.
Experience with Quality Risk Assessments (QRAES), Change Control, nonconformance management, CAPA, and validation practices.
Experience working with Maximo or similar computerized maintenance management systems.
Ability to prepare, submit, and manage Purchase Orders (POs).
Experience working with and escorting vendors and contractors.
Strong organizational skills and ability to manage multiple tasks, projects, and priorities concurrently.
Independent, self-motivated, highly organized, and effective in project-based environments.
Strong collaboration, facilitation, and interpersonal skills.
Work Schedule
1st shift (8-hour schedule)
Flexibility required to support 24/7 operations, including occasional after-hours engineering coverage as needed
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
