- Collaborate closely with the controls and automation team supporting GMP biologics to deliver comprehensive documentation, encompassing both SDLC and non-SDLC needs.
- Assist in drafting, editing, reviewing, and approving documentation within the system development lifecycle (SDLC), including Quality Assurance Plans (QAP), Requirement/Configuration Specifications (RSCS), and Quality Assurance Summary Plans (QASR).
- Support system upgrades, configuration changes, and data integrity remediation efforts led by engineering, ensuring documentation alignment.
- Work in tandem with quality engineering to integrate requirements testing into protocols effectively.
- Develop and approve Standard Operating Procedures (SOPs) to streamline process development and equipment qualification within the facility.
- Extend support to other documentation initiatives, such as SOP writing, to meet organizational needs.
- 1+ year of previous experience from a GxP facility, particularly in conducting clinical drug safety assessment testing in in vivo test models, including sample collection, processing, and basic analysis.
- Experience developing, revising, and implementing training documentation, including SOPs, job aids, and process changes.
- Experience training new technicians and coordinating with vendors.
- GxP (GMP, GLP) data review and quality control standards.
- Possess a bachelor's degree in science or engineering.
- Exhibit a strong grasp of GxP (GMP, GLP) documentation, with hands-on experience in SOP authoring.
- Preferred experience in computer and/or automation systems, including Microsoft Windows Server, Active Directory, networking, Secure Desktop, Open Lab, Acronis, PI, Unicorn, Rockwell Ignition PLC, and Emerson DeltaV.
- Proficient in Microsoft Office suite.
- Showcased skills in project implementation, ensuring timely and effective execution.
- Basic understanding of GxP regulations and operations, with a focus on compliance.
- Demonstrate exceptional technical writing abilities, ensuring clarity and precision in documentation.
- Communicate effectively across teams and stakeholders.
- Possess a background in laboratory experience and techniques.
- Accumulation of at least 1 year of experience in SDLC processes.
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Automation Technical Writer - King of Prussia, United States - Valspec
Description
Job Description
Job DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
Automation Technical Writer
Responsibilities:
The ideal candidate has this preferred experience currently:
Skills and Experience:
Apply today
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.
Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.
Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
