Sr. Validation Specialist Job at PACIV
PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is looking for a Sr. Validation Specialist, for its Puerto Rico office .
Geographical Area: East, PR
Summary
: Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.
FUNCTIONS
Knowledge:
Problem Solving:
Discretion/Latitude:
Impact:
Leadership:
Liaison:
Regulatory:
FUNCTIONS
- Able to troubleshoot systemic validation issues.
- Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.
- Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
- Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
- Develop validation engineering policies and procedures that affect multiple organizational units.
- Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
- Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
- Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
- Prompt and regular attendance to the workplace.
- Other functions may be assigned
Knowledge:
- Advanced validation knowledge (equipment qualification, cleaning, sterilization).
- Applies extensive technical validation expertise, and has full knowledge of other related disciplines.
Problem Solving:
- Provide technical solutions to a wide range of difficult problems.
- Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
Discretion/Latitude:
- Exercises considerable latitude in determining technical objectives of assignment.
- Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.
Impact:
- Essential to the completion of broad programs and projects.
- Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.
Leadership:
- Leads efforts of group of peers directly supervises staff or project resources.
- Guides the successful completion of major programs and may function in a project leadership role.
- May be expected to directly supervise staff or project resources.
Liaison:
- Represents the organization as the prime technical contact on contracts and projects.
- Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Regulatory:
- Understands regulatory trends in industry and able to make connection between those trends and established corporate direction.
- Some direct experience with FDA or equivalent regulatory body.
- Represents the organization as the technical expert to endorse the organization's validation programs and practices
Preferred Qualifications: Validation expertise, Sterilization, Autoclaves, Isolators & Depyrogenation, Kaye Validator & Data loggers, Equipment Qualification, Re-qualification. Availability to support non-standards shift that may include extended and/or weekend shifts as per business needs.
Education: Engineering or Science Degree
Doctorate degree, or Master's degree and 3 years of validation experience, or Bachelor's degree and 5 years of validation experience, or Associate's degree and 10 years of validation experience, or High school diploma / GED and 12 years of validation experience.
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