Senior Specialist, Equipment Commissioning & Qualification

Senior Specialist

The Senior Specialist supports the successful operation of facilities, laboratories, and business functions at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Process Equipment projects and ongoing work activities of low to moderate complexity, individually and with support of others. The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit. The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short-term projects according to established policies and procedures.

The Senior Specialist supports the Commissioning, Qualification, and Validation team as an individual contributor to:

• Author, review, approve, and execute equipment qualification protocols, plans, summary reports, protocol deviations, and other validation deliverables as required.
• Author, review, and approve equipment risk assessments, system categorization assessments, and change control impact assessments.
• Propose, present, and execute change controls for equipment introduction, modification, and retirement. Provide input and feedback for change strategy, qualification approach, compliance gaps, and risk mitigation.
• Review and approve calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests within the computerized maintenance management system.

Procure new CQV equipment and implement associated procedures to support process equipment qualifications. Train new users to operate CQV equipment and troubleshoot as needed.

• Create, revise, and periodically review procedural documents for CQV equipment such as temperature and humidity mapping systems, CO2 instruments, and LN2 foggers.
• Coordinate system usage to maintain CQV timelines while adhering to system calibration and maintenance schedules.
• Perform data integrity risk assessments, audit trail reviews, and user access reviews for CQV equipment.

Lead and support workflows related to quality events and actions including deviations, investigations, proactive initiatives, and corrective and preventive actions.

• Create, revise and periodically review CQV program SOPs and associated work instructions/practices.
• Administer and perform system periodic reviews and CQV document periodic reviews, and review/approve corresponding deliverables. Periodically update the CQV validated systems list.
• Ensure manufacturing and laboratory equipment is maintained in a validated state in compliance with GMP, BMS standards, and health authority regulations. Serve as a subject matter expert for equipment qualification in internal and regulatory audits.

The Senior Specialist contributes essential skills, competencies, and experience necessary for equipment commissioning and qualification, including:

• BS in an Engineering/Science discipline required or minimum of 6 years of experience leading equipment qualifications.
• Minimum of 6 years of experience in FDA-regulated industry.
• Minimum of 4 years of experience developing and executing equipment qualifications, process validations, and/or test method validations.
• Strong background and experience in laboratory and manufacturing operations, with advanced knowledge of cGMP pharmaceutical manufacturing and associated process equipment utilized for cell therapy clinical manufacturing.
• Experience executing temperature/humidity mapping qualifications for controlled storage areas and/or controlled temperature units (incubators, refrigerators, freezers, cryogenic storage systems) is required.
• Highly preferred experience designing and performing airflow visualization studies for biological safety cabinets, isolators, and controlled/classified areas.
• Preferred experience commissioning and qualifying isolators and filling/capping equipment, with a technical background and basic understanding of operation and changeover of aseptic fill/finish technology.
• Process oriented with strong problem solving and critical thinking skills. Adaptive and able to develop new and improved strategies, approaches, and procedures.
• Excellent technical writing skills and proficiency with Microsoft Word formatting functions. Detail oriented and technically accurate author and reviewer of documents for system lifecycle deliverables in alignment with the site validation program. Highly attentive to spelling, grammar, punctuation, and overall document quality.
• Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Independently and effectively manage multiple tasks and activities simultaneously.
• Excellent communication and interpersonal skills; communicate effectively, efficiently, and in a timely manner. Experience dealing with a diverse workforce; team oriented and professionally mature.
• Highly proficient in Microsoft Office Suite Word, Excel, PowerPoint and Outlook. Working knowledge of scheduling software, material inventory management systems, calibration/maintenance management systems, and environmental monitoring systems.
• Strong understanding of quality management systems, document management systems, records management, and data integrity principles.
• Experience interacting with external and/or internal auditors in a compliance audit environment, with direct interaction including face to face interaction in response to audit questions is preferred.