The Role
Support regulated manufacturing operations by troubleshooting equipment/systems, implementing process modifications, and driving continuous improvement. Manage documentation, change control, risk assessments, commissioning/decommissioning, and cross-functional coordination. Support deviations, equipment qualification, process validation, and non-standard 24/7 shift coverage as needed.
Summary Generated by Built In
Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
First Shift
Job Description:
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in manufacturing. Apply basic engineering principles to the design and implementation of system modifications. Organize, analyze and present interpretation of results for operational issues or engineering projects of minor scope and complexity.
Requirements:
- Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment.
- Strong knowledge of Good Documentation Practices (GDP).
- Experience with change control processes and risk assessments.
- Knowledge of commissioning and decommissioning activities.
- Understanding of asset lifecycle management.
- Ability to coordinate cross-functional teams and stakeholders.
- Experience managing technical documentation and records.
- Capability to execute impact assessments and support regulatory compliance.
- Strong organizational, planning, and project management skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and meet project deadlines.
- Technical troubleshooting and problem-solving skills.
- Experience driving continuous improvement initiatives.
- Self-motivated, detail-oriented, and proactive approach to work.
- Ability to collaborate effectively with Engineering, Operations, Maintenance, Quality, and Validation teams.
Responsibilities:
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures.
- Assistance given for unusual problems
- Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
- Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
- Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
- Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
- Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
- Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
- Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
- Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
- Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.
Education:
- Master's degree or bachelor's degree in engineering & 2 years of Engineering experience
Skills Required
- Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment.
- Strong knowledge of Good Documentation Practices (GDP).
- Experience with change control processes and risk assessments.
- Knowledge of commissioning and decommissioning activities.
- Understanding of asset lifecycle management.
- Ability to coordinate cross-functional teams and stakeholders.
- Experience managing technical documentation and records.
- Capability to execute impact assessments and support regulatory compliance.
- Strong organizational, planning, and project management skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and meet project deadlines.
- Technical troubleshooting and problem-solving skills.
- Experience driving continuous improvement initiatives.
- Self-motivated, detail-oriented, and proactive approach to work.
- Ability to collaborate effectively with Engineering, Operations, Maintenance, Quality, and Validation teams.
- Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.
- Master's degree in engineering, or Bachelor's degree in engineering plus 2 years of engineering experience.
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The Company
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
