Position Summary
Accountable for providing operational, scientific and compliance knowledge support to the Sterile Manufacturing Operations. This incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job functions. Program dates: Monday, June 2 – Friday, August 8, 2025.
Key Responsibilities
- Ensures that Change Controls/Change Actions are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
- Leads Change Control as applicable.
- Facilitates de necessary information related to process to determine requirements for documentation, materials, training, equipment / process modifications, and document revisions.
- Supports establishment of process monitoring parameters and control limits.
- Supports the assessment of deviations and process monitoring data.
- Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality.
- Provides technical assistance to identify, recommend and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMP’s compliance.
- Writes, evaluates and revises the required manufacturing documentation (i.e. SOP’s, MBR’s, etc.) and may assist in providing training on scientific or technical aspects of the processes.
- Assists with generation and execution of validation protocols and reports.
- Leads the execution of CAPA’s and Stand Alones including identifying response plan, execution and revision of associated documentation.
- Generates and executes completion of Change Controls related to manufacturing processes/systems/improvements; procedures development & revision, process validation documentation and execute Change Actions from area-related Change Controls.
- Assists the area leads and supervisory personnel to solve any production technical problem (i.e. Process / equipment troubleshooting, yield, cycle time, quality and productivity).
- Provides alternatives and recommendations to improve and maximize processes and equipment.
- Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.
- Promotes and models the BMS Core Behaviors, facilitating teamwork.
- Supports all site initiatives and any other assignments based on business needs.
Qualifications & Experience
Education:
- Applicants must attend an accredited university in Puerto Rico or reside in Puerto Rico.
- Currently enrolled in a Bachelor’s or Master’s degree program in Science, Engineering or a related field.
Skills:
- Strong organizational and time management skills.
- Excellent written and verbal communication abilities.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and as part of a team.
- Strong attention to detail and problem-solving skills.
- Familiarity with digital tools used in lean operational excellence.
Preferred Qualifications:
- Previous experience in inspection or operations field.
- Previous experience working at GMP environment.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
