Job Title: OneLIMS EM Project Technical Writer
Location: Swiftwater, PA (full onsite)
Duration: 6 months
* **Free parking available onsite**
Position Summary
The OneLIMS EM Project Technical Writer is responsible for supporting the on-time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The individual will perform all tasks in an efficient, cGMP-compliant, and safe manner while supporting the alignment of quality processes and master data within the OneLIMS platform. The role requires the ability to work independently in a fast-paced, regulated environment with changing priorities.
Primary Responsibility
* Align the CPV (Continuous Process Verification) program with global standards.
* Transfer process monitoring trend limits into OneLIMS.
Key Responsibilities
* Design, develop, and maintain technical documentation.
* Edit quality documents, including SOPs, guidelines, and Validation Master Plans (VMPs), ensuring compliance with regulatory requirements.
* Create training materials, including presentation slides and supporting documentation.
* Support future-state process mapping activities.
* Organize, track, and plan master data review activities.
* Track and manage project-specific deliverables.
* Perform all work in compliance with cGMP, safety, and quality standards.
Required Qualifications
* Bachelor's degree in Science or Engineering required.
* Master's or PhD candidates are welcome.
* Minimum of 2 years of relevant experience (additional years of experience will also be considered).
* Experience with LIMS/iLMS.
* Ability to work independently with minimal supervision.
* Strong preference for experience within the **biotechnology or pharmaceutical industry.
* Experience working in a GMP/cGMP-regulated environment.
* Proficiency with Microsoft Word, Excel, PowerPoint, Visio, and Outlook.
* Excellent written and verbal communication skills.
* Strong interpersonal, organizational, and information-gathering skills.
* Ability to work effectively in a collaborative team environment.
Preferred Qualifications
* Familiarity with **OneLIMS**.
* Experience with **Qualipso**.
* Experience with **CPV (Continuous Process Verification)** methodologies.
* Experience with **Sequel**.
Location: Swiftwater, PA (full onsite)
Duration: 6 months
* **Free parking available onsite**
Position Summary
The OneLIMS EM Project Technical Writer is responsible for supporting the on-time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The individual will perform all tasks in an efficient, cGMP-compliant, and safe manner while supporting the alignment of quality processes and master data within the OneLIMS platform. The role requires the ability to work independently in a fast-paced, regulated environment with changing priorities.
Primary Responsibility
* Align the CPV (Continuous Process Verification) program with global standards.
* Transfer process monitoring trend limits into OneLIMS.
Key Responsibilities
* Design, develop, and maintain technical documentation.
* Edit quality documents, including SOPs, guidelines, and Validation Master Plans (VMPs), ensuring compliance with regulatory requirements.
* Create training materials, including presentation slides and supporting documentation.
* Support future-state process mapping activities.
* Organize, track, and plan master data review activities.
* Track and manage project-specific deliverables.
* Perform all work in compliance with cGMP, safety, and quality standards.
Required Qualifications
* Bachelor's degree in Science or Engineering required.
* Master's or PhD candidates are welcome.
* Minimum of 2 years of relevant experience (additional years of experience will also be considered).
* Experience with LIMS/iLMS.
* Ability to work independently with minimal supervision.
* Strong preference for experience within the **biotechnology or pharmaceutical industry.
* Experience working in a GMP/cGMP-regulated environment.
* Proficiency with Microsoft Word, Excel, PowerPoint, Visio, and Outlook.
* Excellent written and verbal communication skills.
* Strong interpersonal, organizational, and information-gathering skills.
* Ability to work effectively in a collaborative team environment.
Preferred Qualifications
* Familiarity with **OneLIMS**.
* Experience with **Qualipso**.
* Experience with **CPV (Continuous Process Verification)** methodologies.
* Experience with **Sequel**.
Job Title: OneLIMS EM Project Technical Writer
Location: Swiftwater, PA (full onsite)
Duration: 6 months
* **Free parking available onsite**
Position Summary
The OneLIMS EM Project Technical Writer is responsible for supporting the on-time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The individual will perform all tasks in an efficient, cGMP-compliant, and safe manner while supporting the alignment of quality processes and master data within the OneLIMS platform. The role requires the ability to work independently in a fast-paced, regulated environment with changing priorities.
Primary Responsibility
* Align the CPV (Continuous Process Verification) program with global standards.
* Transfer process monitoring trend limits into OneLIMS.
Key Responsibilities
* Design, develop, and maintain technical documentation.
* Edit quality documents, including SOPs, guidelines, and Validation Master Plans (VMPs), ensuring compliance with regulatory requirements.
* Create training materials, including presentation slides and supporting documentation.
* Support future-state process mapping activities.
* Organize, track, and plan master data review activities.
* Track and manage project-specific deliverables.
* Perform all work in compliance with cGMP, safety, and quality standards.
Required Qualifications
* Bachelor's degree in Science or Engineering required.
* Master's or PhD candidates are welcome.
* Minimum of 2 years of relevant experience (additional years of experience will also be considered).
* Experience with LIMS/iLMS.
* Ability to work independently with minimal supervision.
* Strong preference for experience within the **biotechnology or pharmaceutical industry.
* Experience working in a GMP/cGMP-regulated environment.
* Proficiency with Microsoft Word, Excel, PowerPoint, Visio, and Outlook.
* Excellent written and verbal communication skills.
* Strong interpersonal, organizational, and information-gathering skills.
* Ability to work effectively in a collaborative team environment.
Preferred Qualifications
* Familiarity with **OneLIMS**.
* Experience with **Qualipso**.
* Experience with **CPV (Continuous Process Verification)** methodologies.
* Experience with **Sequel**.
Location: Swiftwater, PA (full onsite)
Duration: 6 months
* **Free parking available onsite**
Position Summary
The OneLIMS EM Project Technical Writer is responsible for supporting the on-time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The individual will perform all tasks in an efficient, cGMP-compliant, and safe manner while supporting the alignment of quality processes and master data within the OneLIMS platform. The role requires the ability to work independently in a fast-paced, regulated environment with changing priorities.
Primary Responsibility
* Align the CPV (Continuous Process Verification) program with global standards.
* Transfer process monitoring trend limits into OneLIMS.
Key Responsibilities
* Design, develop, and maintain technical documentation.
* Edit quality documents, including SOPs, guidelines, and Validation Master Plans (VMPs), ensuring compliance with regulatory requirements.
* Create training materials, including presentation slides and supporting documentation.
* Support future-state process mapping activities.
* Organize, track, and plan master data review activities.
* Track and manage project-specific deliverables.
* Perform all work in compliance with cGMP, safety, and quality standards.
Required Qualifications
* Bachelor's degree in Science or Engineering required.
* Master's or PhD candidates are welcome.
* Minimum of 2 years of relevant experience (additional years of experience will also be considered).
* Experience with LIMS/iLMS.
* Ability to work independently with minimal supervision.
* Strong preference for experience within the **biotechnology or pharmaceutical industry.
* Experience working in a GMP/cGMP-regulated environment.
* Proficiency with Microsoft Word, Excel, PowerPoint, Visio, and Outlook.
* Excellent written and verbal communication skills.
* Strong interpersonal, organizational, and information-gathering skills.
* Ability to work effectively in a collaborative team environment.
Preferred Qualifications
* Familiarity with **OneLIMS**.
* Experience with **Qualipso**.
* Experience with **CPV (Continuous Process Verification)** methodologies.
* Experience with **Sequel**.
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