Senior Validation Specialist

4 weeks ago

Cranbury, United States CareerBuilder Full time

Responsibilities:

Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
pplies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.
Review and generate quality documents including validation protocols, SOPs, change controls, and non-conformance event records as required.
Excellent 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.
Knowledge of pharmaceutical laboratory and manufacturing systems. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.
Experience executing equipment qualification documents.
bility to interact effectively with laboratory, QA, and Facilities 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 along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation

Requirements:
Direct experience with writing and executing validation protocols is preferred.
Understand scientific strategies and be able to invent new methods or new avenues of investigation.
Good interpersonal/communication/influencing/negotiation skills.
Strong project management skills
bility to communicate effectively at all levels in verbal and written form, including technical/business writing.
Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
Direct or indirect industry knowledge.
bility to work independently or in teams.
BS Degree in Science, Engineering or Math with at least one or more years of experience.
Minimum 5 years of experience in FDA - regulated industry, with 3 years of experience in equipment qualification and computer system validations.

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