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.
Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures.
Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
Familiarity with 21 CFR Part 11 compliance.
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 for manufacturing equipment, systems, utilities, and facilities.
Preferred experience executing temperature/humidity mapping qualifications for controlled storage areas, controlled temperature units (incubators, refrigerators, freezers), and cryogenic storage systems.
Preferred experience executing airflow visualization qualifications (smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas.
Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
bility to interact effectively with cross-functional groups.
Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals and drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors.
Strong computer skills in Microsoft Office Suite - Word, Excel, Power Point, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
Requirements:
BA/BS degree required, BS or more advanced degree in science/engineering preferred
Minimum 4 years of equipment qualification execution and technical writing experience in FDA - regulated industry (pharmaceutical/medical device/biotechnology)
Manage projects of limited scope and complexity.
uthor and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
uthor 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.
Create all documents in compliance with Client standards and policies.
Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.