Validation Engineer IISun Pharmaceuticals, Inc • New York, New York, United States
Validation Engineer II
Sun Pharmaceuticals, Inc
- New York, New York, United States
- New York, New York, United States
À propos
Area Of Responsibility
Supports the execution of equipment validation and maintenance as required
Execute, under supervision, equipment qualification and requalification for manufacturing
Participates in the operation of process equipment as well as associated documentation
Support execution of preventative maintenance of pharmaceutical process equipment and utilities
Supports equipment readiness to support the production schedule and is in proper condition/calibration
Provide operational coverage for manufacturing equipment and utilities
Support production personnel on equipment and utility operation
Support re‑qualification of process equipment, testing & certifications of manufacturing process
Support area manufacturing and new product/process transfer activities
Participates in equipment/utility related CAPAs, Deviations, and Investigations
Review, under supervision, process utilities and equipment logs
Support loading / lyophylization cycle and coordination of equipment
Participates in the troubleshoot and remediate exceptions found during FAT/SAT/IQ/OQ/PQ
Supports timely closure of equipment/utility related CAPAs and/or Change Controls
Support Validation of equipment/utilities/process transfers and re‑qualifications
Support URS/FS/DS engineering documents of process related systems
Other duties as assigned
Work Conditions
Office
Lab
Manufacturing area/clean room area
Maintenance Shop
Exposure to noise, hot and cold, outside elements, some radiation
Physical Requirements
Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
Climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
Close vision; ability to adjust focus
Operate computer/office machines, autoclave, depyrogenation oven, vial filler, freeze dryer, steam generators, power tools
Wear proper gowning and safety equipment as needed
Lift up to 50 lbs.
Travel Estimate Up to 0%
Education and Job Qualification
Bachelors in Science, Engineering or related field preferred or equivalent experience
Experience
Minimum 4+ years related experience preferred
Ability to oversee cGMP validation compliance efforts
Ability to operate and maintain process equipment and utilizes (Sterilizers, Depyrogenation Ovens, Lyophilers, Incubators, CTUs)
Familiarity with FDA cGMP, SOPs and ISO standards
Knowledge of pharmaceutical manufacturing equipment and utilities
Familiarity/Knowledge of aseptic techniques
Excellent organizational skills
The presently‑anticipated base compensation pay range for this position is $104,000 to $115,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an at‑will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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Compétences linguistiques
- English
Avis aux utilisateurs
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