Equipment Commissioning/Qualification Specialist - (Biotech/Pharmaceutical)
- Birmingham, AL
- Contract
- Full-time
Shift is Monday to Friday 8am to 5pm with some required after 5pm and weekends depending on project needs.
Position is onsite: not remoteQualifications:
Bachelor's degree preferably in Engineering or Science discipline.
3 to 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs.Develop URS, SIC and SRA for new and existing aseptic facilities and equipment.
Develop and execute Commissioning(COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and according to specifications.
Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions.
Ensure all documentation is compliant with regulatory requirements and internal quality standards.
Conduct risk assessments and implement mitigation strategies for aseptic processes.
Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughly.
Work independently or within a team environment.
Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the Company.
Proficient in the use of word processing, spreadsheet and presentation software programs. Proficient in use if Kaye Validator AVS and Val Probe Systems.
Knowledge on following equipment qualifications:
Homogenizers
Pump Skids
SIP & CIP Skids
Temperature control units
Tanks
Requalification of CTU'sDevelop and implement validation plans for computerized systems, ensuring that systems are compliant with regulatory standards and internal *** policies.Conduct risk assessments to identify potential issues related to system functionality and data integrity.
Create and maintain comprehensive documentation, including system classification, system overview, test scripts, and reports that demonstrate compliance with regulatory requirements.
Execute CSV protocol, to verify that systems function as intended.Bachelor's degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
Five (5) or more years experience in validation of aseptic pharmaceutical manufacturing processes and systems
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs
Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity
Excellent interpersonal skills
Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the company
Comprehensive knowledge of pharmaceutical manufacturing equipment and processes
Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughlyNesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.