Description:

• 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:

• 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.
• Completed work is reviewed from a relatively long- term perspective, for desired results.
• 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

Education:

• Doctorate degree or Master's degree and 3 years of directly related experience. 
• Bachelor's degree and 5 years of directly related experience. 
• Associate's degree and 10 years of directly related experience.
• High school diploma / GED and 12 years of directly related experience.

Preferred Qualifications: 

• Previous experiences in regulated environment (Biotechnology, Pharmaceutical, Medical Devices, etc.).
• Experience in Validation with preference in Process Validation.

Competencies/Skills:

• In-depth knowledge of validation processes and requirements.
• Interacts effectively with variety of communication and working styles.
• Ability to independently determine when additional internal resources are required to solve problems.
• Ability to handle multiple projects at one time.
• Demonstrated Skills in the following areas: schedule development, facilitation, collaboration.
• Basic project management.
• Completion and follow-up.
• Technical expertise areas of validation engineering.
• Ability to independently determine when additional external resources are required to solve problems.
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools.
• Ability to delegate and manage the project work of others.
• Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation, collaboration, project cost development, conflict resolution, decision making, leadership and teambuilding, management of contractors and vendors.

Work Methodology:

• 100%-On Site
• 5 months (1st Contract)
• Non-Standard Shift (Due to the nature of the work (support to new product introductions, projects optimization and commercial manufacturing) (coverage outside day shift such as second/third shifts, weekends, holidays)
• Professional Service Contract