mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary The Process Improvement & SOP/Training Support Specialist is responsible for driving continuous improvement initiatives, updating Standard Operating Procedures (SOPs), delivering operational training, and supporting change control activities within manufacturing and utilities operations. This role collaborates across cross-functional teams including Manufacturing, Quality, Engineering, and IT/Automation to ensure documentation and business processes remain compliant, efficient, and aligned with regulatory requirements and best operational practices.
Key Responsibilities
Lead and support process improvement initiatives by applying analytical tools, data review, process mapping, and Lean/Six Sigma methodologies.
Review, update, and maintain Standard Operating Procedures (SOPs) to reflect current operations, regulatory expectations, and continuous improvement recommendations.
Develop and deliver training plans and materials to ensure all operations personnel are fully trained in updated SOPs, best practices, and process changes.
Work cross-functionally with Manufacturing, Quality, Engineering, and Operations Technology teams to assess training needs and deliver effective instruction.
Support Change Control activities associated with procedural updates, operational adjustments, and process improvements; help ensure all changes are documented, evaluated, and properly closed in compliance with site procedures.
Assist in the preparation of procedural documentation, training records, and validation deliverables as needed to support audits and inspections (FDA, EMA, regulatory, and corporate).
Review and provide input on process metrics, compliance indicators, and training effectiveness measures; recommend actions to address gaps.
Collaborate with site leadership to identify, plan, and execute projects that improve operational effectiveness, compliance, and workforce competency.
Participate in operational readiness activities for new product introductions, process modifications, and technology transfers, ensuring SOPs and training are aligned with operational requirements.
Support quality events (deviations, CAPA) related to procedural gaps, training deficiencies, and process failures as needed.
Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, Quality Systems, or a related field.
5+ years of experience in process improvement, SOP development, training support, or quality systems in a regulated pharmaceutical environment.
Solid experience supporting SOP updates, technical writing, and documentation control.
Strong experience in training delivery and training materials development for operations or manufacturing personnel.
Demonstrated experience supporting Change Control and procedural compliance.
Deep understanding of cGMP, regulatory expectations, quality systems, and site procedures.
Excellent communication skills (written and verbal), including the ability to train, influence, and engage personnel at all levels.
Proficiency with process improvement methodologies (Lean, Six Sigma, root cause analysis).
Analytical mindset with strong problem solving and data interpretation skills.
Ability to prioritize multiple activities and work collaboratively in a cross-functional environment.
Bilingual proficiency (English and Spanish) preferred, with strong documentation capability in English.
Preferred Qualifications
Experience in pharmaceutical or biotech manufacturing operations, especially within a regulated environment (FDA, EMA, global inspections).
Working knowledge of computerized quality systems, document management systems (e.g., Veeva), and change control platforms (e.g., TrackWise).
Experience with project plans and milestone tracking.
Strong facilitation and presentation skills.
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.