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Validation Engineering Specialist II
4 months ago
Provide specialized validation knowledge and information, which is directly needed to support operations and clients. Complete protocols and reports related to the validation of manufacturing processes, packaging processes (including serialization), Continues Process Verification (CPV), equipment qualification and cleaning. Ensure documents conform to all ThermoFisher Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.
What will you do :
Prepare and execute validation protocols (new and existing clients) and writing reports.
Prepare Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for more complex equipment, facilities and computer systems.
Review/verify data and performs statistical analysis.
Monitor the production scheduling and coordination of validation activities as required
Provide technical/validation expertise and support to Quality Operations/Business or Project management/operations/Pharmaceutics and Process Technology (PPT).
Document review of peer protocols and reports.
Maintain cleaning program and trending cleaning results.
Perform 5 years qualification reviews.
Support equipment swabbing.
Attend client meetings as validation representative (as required)
Support special projects (as required)
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shifts (ifrequired)
How will you get here:
Education:
BSc in Chemistry, Pharmacy, Engineering, or related field.
Experience:
Minimum 3 years’ experience in validation within the pharmaceutical industry.
Previous experience in statistical analysis preferable.
Equivalency :
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills, communication and organizational skills. Strong judgment, decision making and trouble shooting skills. Ability to multi-task, meeting tight deadlines in a fast paced environment. Mini-Tab and data analysis knowledge an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
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