Validation Specialist - PCI Pharma Services

SUMMARY:

The main functions of a Validation Specialist are focused around the qualification of pharmaceutical packaging equipment and validation of the associated processes run on this equipment. These functions include generation and execution of protocols on packaging equipment, generation and execution of process validation protocols, assistance in customer audits, and determination of customer validation needs. The successful candidate will manage multiple projects under moderate supervision.

This position provides technical and project support to the Sales Associates, Customer Service, Project Management, Engineering, Production, Quality Assurance, and to our customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):

A Validation Specialist is expected to lead the business beyond of the normal scope of task-based project validation. Knowledge, experience, personal drive, and creativity will motivate this individual to present new ideas to senior management that will affect the direction of the organization over the next years. These ideas could be focused around:

* Innovation of validation processes and tasks
* Validation trends/standards in the pharmaceutical and contract packaging industries
* Hidden opportunities within existing business or customer requests
* Standardization/harmonization/streamlining of validation activities
A Validation Specialist will perform the following activities under moderate supervision. Some travel (a few days a year) may be required to meet with customers and/or vendors.

* Analyze customer and business needs in determination of a validation strategy.
* Conduct and/or participate in customer meetings and attend off-site meetings.
* Interact with Sales, Engineering, Customer Service, Project Management, Production, Quality Assurance, and customers to determine requirements for new projects
* Creation of protocols/protocol templates (IOQ, OQ/PQ) and validation standards
* Review and approve User Requirement Specifications, Functional Specifications and Engineering Study Protocols
* Participate in customer audits and annual product reviews
* Prepare Equivalencies and Stability protocols
* Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment
* Assist in the Change Control process (TrackWise)
* Coordinate validation efforts with mechanics, operators, and engineering
* Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology.





SUPERVISORY RESPONSIBILITIES:
No Supervising of employees

EDUCATION AND/OR EXPERIENCE:

Bachelor of Science in Engineering or Science or 2 - 3 years relevant experience in equipment, process, computer and/or cleaning qualification/validation required. Experience with Serialization a plus.
Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred.

KNOWLEDGE/SKILLS REQUIREMENTS:

Experience with development and execution of validation protocols for process, equipment, cleaning, and/or computer systems in the pharmaceutical and/or medical device industry
Ability to work on multiple projects at the same time
Ability to meet aggressive timelines
Good interpersonal/teamwork skills
Effective communication skills (verbal and written form)
Effective at leading project teams and interfacing with customers and operations personnel
Must possess and demonstrate motivational and leadership qualities
Must possess excellent problem solving and analytical skills
Must be well organized along with being detail and multi-task oriented
Knowledge and experience in cGMPs and FDA regulations
Knowledge of Six Sigma, DOE, and other improvement techniques a plus

Proficient in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Access, and Microsoft Power Point

Equal Employmnet Opportunity/Vet/Disabled