AM Technical Solutions- Who Are We:
AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.
Commissioning, Qualification, and Validation (CQV) Lead
Massachusetts and Austin, TX
Lead Commissioning, Qualification, and Validation support for Life Science Company:
- Provide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.
- In-depth understanding of the governing standards for medical device sector.
- Act as Project SME for relevant CQV processes, including ASTM E2500, which will be utilized for CQV document creation and field execution.
- Create and manage all documentation produced for the Project, including Plans, SOPs, Strategies, DQ, QRA, RTM, FAT, RV, SAT, IOC, IOQ, and all supporting Final Reports.
- Manage execution of all testing from FAT through to IOQ.
- Prepares & presents project status & targets.
- Collaborate with multiple departments including Manufacturing, Facilities, Engineering, Quality Control, Validation, Quality Assurance, and Regulatory to facilitate agreement on equipment and process operational parameters, test requirements, and acceptance criteria.
- Own and Manage Change Controls to allow for the ongoing maintenance and optimization of Validated systems.
- Generation, execution, and closeout of Commissioning and Validation documentation, including test plans, procedures, and protocols.
- Review and approval of a variety of validation lifecycle documents, include but are not limited to validation and/or project plans, user requirement specifications, SOPs, maintenance documentation, investigation reports, deviation resolution, CAPA closeout, etc.
Direct Involvement Opportunities:
- Provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing and laboratory process controls.
- Communicates current and applicable good manufacturing practices (GMP) and to business partners.
- Executes functions needed to support change control activities and document management requirements.
- Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.
- Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on.
- Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability/reliability.
- Writes/revises or reviews /approves a variety of validation lifecycle documents. Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.
Qualifications, Skills, And Experience:
- Bachelor’s degree or equivalent in Engineering, Science, or related discipline
- 7+ years of experience working in a GMP manufacturing facilities role.
- Ability to effectively communicate with all levels within the organization
- Ability to build collaborative relationships with colleagues and clients
- Demonstrated effectiveness in a dynamic, fast-paced, and ever-changing environment.
- Able to deal with pressure, take on challenging projects, manage competing priorities, and anticipate problems in advance