Validation Specialist

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Summary of Objective:

The main functions of a Validation Lead are focused on the qualification of utilities, computer systems, pharmaceutical packaging equipment and validation of the associated processes run on this equipment. Core functions include generation and execution of packaging equipment qualification protocols, 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:

To perform this job successfully, an individual must be able to perform

each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

A Validation Specialist is expected to lead the business beyond 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.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to

perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

The physical demands described here are representative of those that must be met by an employee to successfully

perform the essential functions of this job.

Must be able to walk, bend and stand repeatedly when performing executions on floor

The employee must occasionally lift and/or move up to 10 pounds

Must be physically capable to perform the above duties with or without reasonable accommodations which may be

made to enable individuals with disabilities to perform the essential functions.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with

disabilities to perform the essential functions.

Office and Production floor environment

• The noise level in the work environment is usually moderate. Appropriate (PPE), as described in EHS policies will be worn to protect against hearing loss.

Must be able to properly gown and work in an active packaging operation.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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

COMPUTER SKILLS:

Proficient in the use of computer software

• Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Access,

and Microsoft PowerPoint.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.