Commissioning & Qualification Specialist
Actalent, birmingham, al, United States
Job Title: Commissioning & Qualification Specialist
Job Description
The Commissioning & Qualification Specialist supports aseptic pharmaceutical manufacturing by ensuring facilities, utilities, and equipment are properly specified, installed, qualified, and documented in compliance with regulatory and quality standards. This role focuses on risk-based commissioning and qualification activities for new and existing aseptic systems, including development of user requirements, execution of COM/IQ/OQ/PQ protocols, and computerized system validation. The specialist collaborates closely with cross-functional teams, manages discrepancies and deviations, and produces audit-ready documentation that demonstrates systems operate as intended and protect product quality and sterility.
Responsibilities
+ Develop User Requirement Specifications (URS) that define clear, testable system requirements aligned with business, compliance, and aseptic manufacturing needs.
+ Prepare System Impact Classifications (SIC) and System Risk Assessments (SRA) to support risk-based validation and ensure qualification efforts focus on product quality and sterility protection.
+ Conduct detailed risk assessments for aseptic processes and implement appropriate mitigation strategies, particularly for SIP/CIP, WFI systems, and hygienic equipment design.
+ Develop and execute Commissioning (COM) and Installation Qualification (IQ) protocols to confirm systems are installed correctly and meet design and URS specifications.
+ Perform Operational Qualification (OQ) and Performance Qualification (PQ) activities to verify that systems operate as intended under all defined operating ranges and conditions.
+ Plan and perform equipment and utility qualification for homogenizers, pump skids, SIP and CIP skids, temperature control units, pressure vessels, and WFI skids.
+ Execute computerized system validation (CSV) test scripts to verify automated system functionality against predefined acceptance criteria.
+ Collect and document objective evidence for all testing, including screenshots, reports, and supporting records, in compliance with GDP and ALCOA+ principles.
+ Identify, document, and manage discrepancies and deviations discovered during IQ, OQ, PQ, and CSV activities, ensuring appropriate assessment, resolution, and traceable documentation.
+ Support change control and requalification assessments to maintain the validated state of systems as they are modified or improved over time.
+ Apply regulatory and quality systems awareness when drafting and reviewing protocols, reports, and supporting documentation to support smooth regulatory inspections.
+ Interpret P&IDs and related technical drawings to support accurate IQ execution and to identify potential installation or configuration issues.
+ Coordinate with calibration and metrology functions to ensure instruments and sensors are suitable and in-tolerance prior to qualification testing.
+ Support vendor activities and FAT/SAT testing to improve system turnover quality and reduce downstream qualification rework.
+ Use thermal validation tools for temperature mapping and SIP effectiveness verification in aseptic systems, and incorporate results into qualification reports.
+ Maintain strict GDP-compliant technical documentation, ensuring that all qualification activities are traceable, audit-ready, and defensible.
+ Collaborate effectively with other workgroups, including engineering, validation, quality, and operations, to ensure projects are completed thoroughly and on schedule.
+ Communicate observations, risks, and outcomes clearly and effectively in both written and verbal form to stakeholders at all levels.
+ Work independently or as part of a team, managing priorities and tasks to support multiple concurrent commissioning and qualification projects.
Essential Skills
+ Hands-on experience with commissioning and qualification activities, including COM, IQ, OQ, and PQ, in regulated environments.
+ Strong experience in validation and validation testing within GMP or similarly regulated pharmaceutical or aseptic manufacturing settings.
+ Proficiency in risk-based validation, including development and execution of System Impact Classifications (SIC) and System Risk Assessments (SRA).
+ Demonstrated ability to develop clear, testable User Requirement Specifications (URS) and maintain requirements traceability throughout the lifecycle.
+ Solid understanding of aseptic processes and contamination control principles, particularly for SIP/CIP systems, WFI, and hygienic equipment design.
+ Equipment and utility qualification expertise for SIP/CIP skids, WFI systems, pressure vessels, pump systems, temperature control units, and homogenizers.
+ Experience with CSV test script execution and data integrity practices to verify automated system functionality against acceptance criteria.
+ Proficiency in deviation and discrepancy management, including assessment, documentation, and compliant resolution of issues identified during qualification.
+ Ability to produce GDP-compliant technical documentation, including protocols, test scripts, reports, and supporting evidence, consistent with ALCOA+ principles.
+ Effective written and verbal communication skills, with the ability to clearly convey technical observations, risks, and conclusions to diverse stakeholders.
+ Proficiency with word processing, spreadsheet, and presentation software for authoring protocols, reports, and presentations.
Additional Skills & Qualifications
+ Familiarity with thermal validation tools used for temperature mapping and SIP verification in aseptic systems.
+ Understanding of GDP and ALCOA+ documentation discipline to ensure data and evidence are audit-ready and defensible.
+ Experience with change control and requalification assessment to maintain validated state throughout system lifecycle.
+ Awareness of regulatory expectations and quality systems to support compliant protocol and report writing, and to facilitate regulatory inspections.
+ Ability to interpret P&IDs and related technical documentation to support accurate installation verification and troubleshooting.
+ Familiarity with automation and controls, including testing alarms, interlocks, recipe controls, and audit trails.
+ Knowledge of data integrity and 21 CFR Part 11 fundamentals for managing electronic records and electronic signatures in automated systems.
+ Experience coordinating with calibration and metrology teams to confirm instrument suitability prior to qualification testing.
+ Root cause analysis and CAPA-oriented thinking to support effective deviation resolution and continuous improvement.
+ Experience supporting vendor activities and FAT/SAT to improve system turnover quality and reduce qualification rework.
+ Interest in a contract role with potential transition to a permanent position upon successful performance and business need.
Work Environment
The role is based 100% on-site in a pharmaceutical contract development and manufacturing facility with aseptic and laboratory operations. Work takes place primarily in a regulated lab and production environment that follows Good Manufacturing Practice principles and strict documentation standards. The position involves frequent interaction with processing equipment such as SIP/CIP skids, WFI systems, pressure vessels, pump skids, temperature control units, and homogenizers, as well as computerized and automated control systems. The specialist regularly uses standard office software tools for documentation and reporting, and may work in close proximity to active utilities and process areas while adhering to site safety and gowning procedures appropriate for aseptic and laboratory spaces. The environment is collaborative and project-driven, with cross-functional teamwork and a focus on delivering high-quality, audit-ready qualification packages, and offers the opportunity to transition from an initial fixed-term engagement into a permanent role based on performance and organizational needs.
Job Type & Location
This is a Contract position based out of Birmingham, AL.
Pay and Benefits
The pay range for this position is $80.00 - $83.50/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 May 1, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.
Job Description
The Commissioning & Qualification Specialist supports aseptic pharmaceutical manufacturing by ensuring facilities, utilities, and equipment are properly specified, installed, qualified, and documented in compliance with regulatory and quality standards. This role focuses on risk-based commissioning and qualification activities for new and existing aseptic systems, including development of user requirements, execution of COM/IQ/OQ/PQ protocols, and computerized system validation. The specialist collaborates closely with cross-functional teams, manages discrepancies and deviations, and produces audit-ready documentation that demonstrates systems operate as intended and protect product quality and sterility.
Responsibilities
+ Develop User Requirement Specifications (URS) that define clear, testable system requirements aligned with business, compliance, and aseptic manufacturing needs.
+ Prepare System Impact Classifications (SIC) and System Risk Assessments (SRA) to support risk-based validation and ensure qualification efforts focus on product quality and sterility protection.
+ Conduct detailed risk assessments for aseptic processes and implement appropriate mitigation strategies, particularly for SIP/CIP, WFI systems, and hygienic equipment design.
+ Develop and execute Commissioning (COM) and Installation Qualification (IQ) protocols to confirm systems are installed correctly and meet design and URS specifications.
+ Perform Operational Qualification (OQ) and Performance Qualification (PQ) activities to verify that systems operate as intended under all defined operating ranges and conditions.
+ Plan and perform equipment and utility qualification for homogenizers, pump skids, SIP and CIP skids, temperature control units, pressure vessels, and WFI skids.
+ Execute computerized system validation (CSV) test scripts to verify automated system functionality against predefined acceptance criteria.
+ Collect and document objective evidence for all testing, including screenshots, reports, and supporting records, in compliance with GDP and ALCOA+ principles.
+ Identify, document, and manage discrepancies and deviations discovered during IQ, OQ, PQ, and CSV activities, ensuring appropriate assessment, resolution, and traceable documentation.
+ Support change control and requalification assessments to maintain the validated state of systems as they are modified or improved over time.
+ Apply regulatory and quality systems awareness when drafting and reviewing protocols, reports, and supporting documentation to support smooth regulatory inspections.
+ Interpret P&IDs and related technical drawings to support accurate IQ execution and to identify potential installation or configuration issues.
+ Coordinate with calibration and metrology functions to ensure instruments and sensors are suitable and in-tolerance prior to qualification testing.
+ Support vendor activities and FAT/SAT testing to improve system turnover quality and reduce downstream qualification rework.
+ Use thermal validation tools for temperature mapping and SIP effectiveness verification in aseptic systems, and incorporate results into qualification reports.
+ Maintain strict GDP-compliant technical documentation, ensuring that all qualification activities are traceable, audit-ready, and defensible.
+ Collaborate effectively with other workgroups, including engineering, validation, quality, and operations, to ensure projects are completed thoroughly and on schedule.
+ Communicate observations, risks, and outcomes clearly and effectively in both written and verbal form to stakeholders at all levels.
+ Work independently or as part of a team, managing priorities and tasks to support multiple concurrent commissioning and qualification projects.
Essential Skills
+ Hands-on experience with commissioning and qualification activities, including COM, IQ, OQ, and PQ, in regulated environments.
+ Strong experience in validation and validation testing within GMP or similarly regulated pharmaceutical or aseptic manufacturing settings.
+ Proficiency in risk-based validation, including development and execution of System Impact Classifications (SIC) and System Risk Assessments (SRA).
+ Demonstrated ability to develop clear, testable User Requirement Specifications (URS) and maintain requirements traceability throughout the lifecycle.
+ Solid understanding of aseptic processes and contamination control principles, particularly for SIP/CIP systems, WFI, and hygienic equipment design.
+ Equipment and utility qualification expertise for SIP/CIP skids, WFI systems, pressure vessels, pump systems, temperature control units, and homogenizers.
+ Experience with CSV test script execution and data integrity practices to verify automated system functionality against acceptance criteria.
+ Proficiency in deviation and discrepancy management, including assessment, documentation, and compliant resolution of issues identified during qualification.
+ Ability to produce GDP-compliant technical documentation, including protocols, test scripts, reports, and supporting evidence, consistent with ALCOA+ principles.
+ Effective written and verbal communication skills, with the ability to clearly convey technical observations, risks, and conclusions to diverse stakeholders.
+ Proficiency with word processing, spreadsheet, and presentation software for authoring protocols, reports, and presentations.
Additional Skills & Qualifications
+ Familiarity with thermal validation tools used for temperature mapping and SIP verification in aseptic systems.
+ Understanding of GDP and ALCOA+ documentation discipline to ensure data and evidence are audit-ready and defensible.
+ Experience with change control and requalification assessment to maintain validated state throughout system lifecycle.
+ Awareness of regulatory expectations and quality systems to support compliant protocol and report writing, and to facilitate regulatory inspections.
+ Ability to interpret P&IDs and related technical documentation to support accurate installation verification and troubleshooting.
+ Familiarity with automation and controls, including testing alarms, interlocks, recipe controls, and audit trails.
+ Knowledge of data integrity and 21 CFR Part 11 fundamentals for managing electronic records and electronic signatures in automated systems.
+ Experience coordinating with calibration and metrology teams to confirm instrument suitability prior to qualification testing.
+ Root cause analysis and CAPA-oriented thinking to support effective deviation resolution and continuous improvement.
+ Experience supporting vendor activities and FAT/SAT to improve system turnover quality and reduce qualification rework.
+ Interest in a contract role with potential transition to a permanent position upon successful performance and business need.
Work Environment
The role is based 100% on-site in a pharmaceutical contract development and manufacturing facility with aseptic and laboratory operations. Work takes place primarily in a regulated lab and production environment that follows Good Manufacturing Practice principles and strict documentation standards. The position involves frequent interaction with processing equipment such as SIP/CIP skids, WFI systems, pressure vessels, pump skids, temperature control units, and homogenizers, as well as computerized and automated control systems. The specialist regularly uses standard office software tools for documentation and reporting, and may work in close proximity to active utilities and process areas while adhering to site safety and gowning procedures appropriate for aseptic and laboratory spaces. The environment is collaborative and project-driven, with cross-functional teamwork and a focus on delivering high-quality, audit-ready qualification packages, and offers the opportunity to transition from an initial fixed-term engagement into a permanent role based on performance and organizational needs.
Job Type & Location
This is a Contract position based out of Birmingham, AL.
Pay and Benefits
The pay range for this position is $80.00 - $83.50/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 May 1, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.