Commissioning & Qualification Specialist - Birmingham, AL
Location: Birmingham, AL (onsite)
Shift: Monday-Friday, 8am to 5pm (some weekends depending on project needs)Responsibilities:
- 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.
- 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, and Requalification of CTU’s
- Develop and implement validation plans for computerized systems, ensuring that systems are compliant with regulatory standards and internal Evonik 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 Engineering or Science discipline. Other disciplines and/or equivalent job experience will be considered
- 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
- 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 thoroughly
- Work independently or within a team environment.
Recommended Jobs
1454 - Electrical Engineer
Sigma Defense is currently seeking an Electrical Engineer to join our team in Huntsville, AL. Equal Opportunity Employer/Veterans/Disabled: Sigma Defense Systems is an Equal Opportunity Employ…
Evening Babysitter for Toddler
We are seeking a responsible and caring babysitter for our 2-year-old son in Birmingham, AL. The job is scheduled from Monday, December 15, 2025, at 11:00 PM to Tuesday, December 16, 2025, at 04:00 AM…
MSP Business Development Manager
The MSP business is one of Rubrik's fastest growing segments. The MSP Business Development Manager role is highly visible and strategic. You will help develop our MSP partner base by creating new serv…
Histotechnician
Melissa Owens| President P: (386)339-0839 |E: [email protected] Schedule a Meeting: Histotechnician OR Histotechnologist- TEMPORARY/CONTRACT in Huntsville, AL 35805 …
ICU RN Internal Contract, Nights
At ScionHealth , we empower our caregivers to do what they do best. We value every voice by caring deeply for every patient and each other. We show courage by running toward the challenge and…
High-Powered Microwave (HPM) / Radio Frequency (RF) /...
Avion Solutions Inc., an employee-owned company, seeks candidates for a High-Powered Microwave (HPM) / Radio Frequency (RF) / Electronic Warfare (EW) Engineer to support the US Army at Redstone Ar…
To Go Specialist
WE ARE LONGHORN. Legendary food and service begins with legendary people. We believe in earning the loyalty of our Team Members with our strong, diverse culture, well-done benefits and growth opport…
RT Vent - Field (Mobile)
Description: Position Summary: The RT Vent Field Clinician is a Respiratory Therapist providing respiratory patient care to Vent patients for optimal outcomes. Provides respiratory care to patient…
Utilization Review Pharmacist
Utilization Review Pharmacist Shape the drug benefit landscape—analyze and optimize medication use. Key Responsibilities: Review prescribing trends and propose cost-saving alternatives. M…
CDL-A OTR Drivers
CDL-A Drivers: Earn Up To $1500+/Wk (paid hrly or cpm)! 100% No Touch Take Advantage of Our Freight Network & Decked Out Trucks To Log Big Miles and Earn Big Paychecks! AMX Network Driver Benefits…