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Validation Engineer I

Validation

~~PRIMARY TASKS:
? Responsible for all Cleaning Validation activities for solid and liquid dose products.
? Generate Cleaning Validation protocols, reports, and SOPs
? Swab equipment and submit samples to lab for analysis
? Perform investigations for any cleaning failures
? Support continuous improvement activities for the validation program to ensure efficiency, effectiveness, and compliance. 
? Generation, review, and approval of validation documentation and execution of validation studies in accordance with FDA regulations/guidelines.
? Review, analyze, and assess executed data and generate necessary summaries and validation/qualification reports.
? Assist with process validations and/or equipment qualifications as necessary
? Perform other duties as may be assigned by the management.

SKILLS NEEDED:
? Must have excellent problem solving skills.
? Strong analytical skills with an ability to use scientific knowledge and statistical methods to identify issues and assess acceptability of system and process performance.
? Strong communication, organization and time management skills are necessary.
? Ability to prioritize work per business needs in a fast-paced environment.
? High degree of accuracy and attention to details.
? Ability to make decisions based on expertise and customer/business requirements.
? Ability to perform essential functions and responsibilities with little to no supervision.
? Proficient in Access database, MS Excel and MS word.
? Excellent interpersonal skills, team work oriented with a positive attitude.


EDUCATION/TRAINING:
? Bachelors Degree in Chemistry, Pharmaceutical Science, Science, or equivalent work experience.
? 2+ experience in Quality, Process, Validation, Tech Service, and /or Testing.
? Possess a working knowledge of pharmaceuticals manufacturing of solid and liquid products, or related field
? Preferred -Working knowledge and experience in cleaning validation and current validation trends and processes desired.
? Experience in maintaining, follow up and implementation of CAPA system desired.


PHYSICAL DEMAND/WORK ENVIRONMENT
Job requires standing and sitting as needed.  Walking, primarily on a level surface, periodically throughout the day is also required.  Reaching above shoulder height, below the waist and/or lifting may be required to file documents or store materials throughout the workday.  Proper lifting techniques required.  Activities may include occasional lifting up to 50 pounds for files, computer printouts and other mostly office related items.

The performance of this position occasionally requires exposure to manufacturing areas where, under certain circumstances, personal protective equipment such as safety glasses with side shields and hearing protection are mandatory.  The primary environment will be ambient room temperature, office lighting and exposure to traditional office equipment as found in a typical office environment.

 

Location - Validation

 
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