C&Q Specialist - Tech Transfer - contractor (hybrid job)

CIS International•Hillsboro, OR

8d•Hybrid

About The Position

The C&Q Specialist will be responsible for the full lifecycle support of a new filling line and its ancillary equipment, from design through Commissioning and Qualification (C&Q), also Technology Transfer activities for this project in Hillsboro, Oregon, USA. The C&Q Specialist will ensure that new or transferred products, processes, equipment, and systems are introduced into the manufacturing environment in a compliant, validated, and operationally ready state. This position supports Technology Transfer (TT) initiatives by executing commissioning, qualification, and verification activities aligned with regulatory, quality, and operational requirements. The specialist collaborates cross‑functionally to ensure that equipment, utilities, facilities, and processes meet intended use and performance criteria before commercial release.

Requirements

Full lifecycle support of a new filling line and its ancillary equipment
Commissioning and Qualification (C&Q) activities
Technology Transfer (TT) activities
Ensure products, processes, equipment, and systems are introduced in a compliant, validated, and operationally ready state
Execute commissioning, qualification, and verification activities aligned with regulatory, quality, and operational requirements
Collaborate cross-functionally
Develop, author, and execute C&Q protocols (IQ/OQ/PQ)
Focus on aseptic processing and clean room standards
Prepare and manage Planned Event (PE) records and Change Control documentation
Travel to equipment vendor sites for Site Acceptance Tests (SATs)
Participate in process mapping, gap assessments, and readiness evaluations
Support definition of URS, process requirements, equipment specifications, and acceptance criteria
Assist in transferring process knowledge, critical parameters, and control strategies
Coordinate with R&D, Process Engineering, Quality, and Operations
Prepare and maintain C&Q documentation (protocols, reports, traceability matrices, risk assessments)
Ensure alignment with validation master plans, technology transfer plans, and project timelines
Support change controls, impact assessments, and regulatory documentation
Maintain audit-ready documentation
Support internal/external inspections

Nice To Haves

Willing to support non-admin hours

Responsibilities

Develop, author, and execute C&Q protocols (IQ/OQ/PQ) for the new filling line, focusing on aseptic processing and clean room standards, which require redundant power, cooling, and high business continuity importance.
Collaborate with Quality Assurance (QA) to ensure all C&Q documentation supports the Provisional and Final Release for GMP use of controlled classified areas.
Prepare and manage Planned Event (PE) records and Change Control documentation for the project, ensuring all revisions and updates are submitted to the HTO Change Control team and reviewed by the CAPA Review Board (CRB) as necessary.
Travel to equipment vendor sites as needed per the project schedule, including but not limited to Site Acceptance Tests (SATs), ensuring all business-related travel costs (accommodation, airfare, meals) are coded to the employee’s home functional cost center.
Participate in process mapping, gap assessments, and readiness evaluations for incoming or outgoing product/process transfers.
Support the definition of URS, process requirements, equipment specifications, and acceptance criteria.
Assist in transferring process knowledge, critical parameters, and control strategies from sending to receiving sites.
Coordinate with R&D, Process Engineering, Quality, and Operations to ensure seamless TT execution.
Prepare and maintain C&Q documentation, including protocols, reports, traceability matrices, and risk assessments.
Ensure alignment with validation master plans, technology transfer plans, and project timelines.
Support change controls, impact assessments, and regulatory documentation related to TT and C&Q activities.
Maintain audit‑ready documentation and support internal/external inspections.