Validation Engineer Pharma Onsite Warren Nj

JOB DESCRIPTION

 
 
Validation Engineer     Pharma (Onsite     Warren, NJ)  
 
 
 
  
 We are seeking a Validation Engineer for a global pharmaceutical company. You will be responsible for supporting the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. You will also contribute to the completion of milestones associated with facility, utility, and equipment qualification. 
 
 
 
This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite  role in Warren, NJ. 
 
 
 
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.  
 
 
 
Responsibilities: 
 
 
 
 
 
Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.  
 
 
 
 
 
 
 
Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures  
 
 
 
 
 
 
 
Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.  
 
 
 
 
 
 
 
Familiarity with 21 CFR Part 11 compliance.  
 
 
 
 
 
 
 
Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.  
 
 
 
 
 
 
 
Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.  
 
 
 
 
 
 
 
Preferred experience executing temperature/humidity mapping qualifications for controlled storage areas, controlled temperature units (incubators, refrigerators, freezers), and cryogenic storage systems  
 
 
 
 
 
 
 
Preferred experience executing airflow visualization qualifications (smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas  
 
 
 
 
 
 
 
Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.  
 
 
 
 
 
 
 
Strong computer skills in Microsoft Office Suite     Word, Excel, Power Point, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.  
 
 
 
 
 
 
 
Manage projects of limited scope and complexity.  
 
 
 
 
 
 
 
Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.  
 
 
 
 
 
 
 
Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.  
 
 
 
 
 
 
 
Develop written procedures for operation, cleaning, and maintenance of equipment and systems.  
 
 
 
 
 
Requirements:  
 
 
 
 
 
BA/BS degree required, BS or more advanced degree in science/engineering preferred  
 
 
 
 
 
 
 
Minimum 4 years of equipment qualification execution and technical writing experience in FDA     regulated industry (pharmaceutical/medical device/biotechnology)  
 
 
 
 
 
 
 
Please submit your resume to our network at  (please apply to the Validation Engineer     Pharma (Onsite     Warren, NJ)  role).  
 
 
 
Please feel free to forward this project opening to others who may be interested.  
 
 
 
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.  
 
 
 
Compensation: $45/hr. - $51.86/hr.