Commissioning & Qualification Specialist

Commissioning and Qualification Specialist Job Description As a Commissioning and Qualification Specialist, you will play a crucial role in the validation and qualification of aseptic pharmaceutical processes and equipment. You will ensure compliance with regulatory requirements and internal quality standards, contributing to the successful execution of projects. Responsibilities + Develop User Requirements Specifications (URS), System Impact Classification (SIC), and System Risk Assessment (SRA) for new and existing aseptic facilities and equipment. + Create and execute Commissioning (COM) and Installation Qualification (IQ) protocols to ensure proper installation according to specifications. + Perform Operational Qualification (OQ) and Performance Qualification (PQ) activities to verify system functionality under various conditions. + Ensure all documentation adheres to regulatory requirements and internal quality standards. + Conduct risk assessments and implement mitigation strategies for aseptic processes. + Collaborate effectively with other workgroups to complete projects on time and thoroughly. + Communicate observations and outcomes effectively through written and verbal means to all levels within the company. + Utilize word processing, spreadsheet, and presentation software proficiently. + Proficiently use Kaye Validator AVS and Val Probe Systems. + Develop and implement validation plans for computerized systems, ensuring compliance with regulatory standards. + Conduct risk assessments to identify potential issues related to system functionality and data integrity. + Create and maintain comprehensive documentation, including system classification, overview, test scripts, and compliance reports. Essential Skills + Bachelor's degree, preferably in Science or a related discipline. + 3 to 5 years of experience in validation and qualification of aseptic pharmaceutical processes and equipment. + Strong understanding of FDA/EU Regulatory Guidance Framework, GMPs, and industry best practices. + Proficiency in developing URS, SIC, SRA, validation plans, and maintaining compliant documentation. + Experience in validating computerized systems and ensuring data integrity. + Knowledge of pharmaceutical equipment such as homogenizers, pump skids, SIP/CIP skids, CTUs, and tanks. Additional Skills & Qualifications + Five or more years of experience in validation of aseptic pharmaceutical manufacturing processes and systems. + Comprehensive knowledge of pharmaceutical manufacturing equipment and processes. + Skill in MS Office tools and specialized systems like Kaye Validator AVS and Val Probe. Job Type & Location This is a Contract position based out of Birmingham, AL. Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Birmingham,AL. Application Deadline This position is anticipated to close on Dec 17, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.