AllSTEM Connections: Technical Writer (Temp)

Developer is needed in Lansdale, United States.

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Client: AllSTEM Connections

Location: Lansdale, PA

Contract: Temporary, Contract

Candidate will:

• Support upgrades, configuration changes
• Author computer system validation documents, including requirement specifications, configuration specifications, requirements traceability matrices, system document indices, retirement plans, and for new systems, QAP and QASR documents also. He / she will work closely with team engineers dedicated to DI remediation as well as the client Automation team. Work with Quality Engineering to support protocol authoring for inclusion of requirements testing.
• Prepare standard operating procedure (SOP) and guidelines, new and updates, with support from subject matter experts.
• Working in teams. Mix of on site and remote work.
• Meet often changing deadlines due to the nature of pharmaceutical clinical manufacturing. Provide support for the client WP17 BCMT Pilot Plant Data Integrity (DI) remediation project.

The objective of the project is to remediate system with data integrity gaps. The documentation specialist will support the project engineers and lead. Support will include updates to existing Software Development Life Cycle documents for qualified equipment/instruments and automated/IT systems, including the documents listed above. Equipment could be benchtop lab instruments, industrial systems such as glasswashers and autoclaves, or process control or infrastructure systems used in the pharmaceutical clinical manufacturing space.

Candidate will:

• Same as project #1 but not driven by Data Integrity remediation.
• Scope will include existing and new systems that are outside the scope of data integrity remediation project. This could be existing systems undergoing improvements or functional upgrades or entirely new systems.
• Migration document from MIDAS/MEDs to eVal.
• Learning equipment automation to assist with writing is the documents
• Written Deliverables, Including Any Reports. Support the WP17 BCMT Pilot Plant automation team. He will be supporting computer system remediation on a wide variety of local clinical manufacturing systems (benchtop lab and manufacturing scale) to close DI gaps. Systems are primarily Windows based, with some OEM PLC based. Some networked, some not.
• Other responsibilities: Maintain department training, safety training and attend related meetings, in person and remote, in support of safety culture (non-capitalizable expense labor). R on-line end user guides to applications associated with the implementation of new technology in large, complex computer systems such as project CRISP.

Pay: $30.16 - $45.81 per hour