Technical Writing Specialist Pharma (Onsite Warren, NJ)
We are seeking a Technical Writing Specialist for a global pharmaceutical company. You will be supporting the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers.
This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Warren, NJ.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities:
Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
Ability to read and interpret engineering manuals/drawings relevant to the assigned task.
Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.
Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
Requirements:
BA/BS degree required, BS or more advanced degree in science/engineering preferred
Minimum 5 years of experience in technical writing, with 3 years of technical writing experience in the pharmaceutical industry
Ability to execute validations in an aseptic environment
Please submit your resume to our network at (please apply to the Technical Writing Specialist Pharma (Onsite Warren, NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $45/hr. - $51.75/hr.
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