Sr Specialist Tech Engineering
Juncos - Puerto Rico
Job Summary
- Provide primary support for Quality Systems activities including deviations CAPAs Change Controls and related quality documentation.
- Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
- Work closely with the Quality team and relevant stakeholders to initiate implement monitor and close effective CAPAs in a timely manner.
- Ensure Quality Systems records are complete accurate compliant and inspection-ready.
- Facilitate and manage documentation changes related to facilities and engineering processes.
- Ensure that documentation changes adhere to regulatory guidelines internal quality standards and industry best practices.
- Collaborate with relevant stakeholders to implement documentation changes efficiently.
- Provide support for the creation completion review routing and tracking of OEFM electronic forms.
- Ensure OEFM electronic forms are completed accurately maintained in accordance with applicable procedures and processed within required timelines.
- Collaborate with F&E Quality and other cross-functional teams to resolve form-related questions or issues.
- Support the transformation of the Pest Control program into a state of the art program.
- Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
- Support the documentation and records related to the pest control program.
- Support the Change Control process by evaluating proposed changes to facilities utilities equipment and critical utilities.
- Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
- Maintain Change Control records and provide support during regulatory inspections.
- Education: Doctorate degree and 2 years of Engineering experience or Masters degree and 6 years of Engineering experience or Bachelors degree and 8 years of directly related experience
- Strong knowledge and demonstrated experience with Quality Systems particularly deviations CAPA management Change Controls and controlled documentation.
- Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred.
- Some understanding of pest control programs within a regulated manufacturing environment.
- Knowledge of regulatory requirements including FDA and other relevant authorities.
- Excellent organizational communication and problem-solving skills.
- Detail-oriented with a focus on quality compliance and timely execution.
Required Skills:
Education: Doctorate 2 years of Project Management experience or Masters 4 years of Project Management experience or Bachelors 6 years of Project Management experience or Associates 10 years of Project Management experience or High school/GED 12 years of Project Manage Change Control experience Fluent business English and Spanish written and oral Effective verbal and written communication skills (writing and presentations). Understanding and experience with Ariba Sourcing and Contracting Modules. Experience with SAP Trackwise and Project management tools preferred. Highly proficient with MS Office including Excel Word and PowerPoint Practical project management software and spreadsheet skills proficient computer operation skills.
Required Education:
Bachelors Degree