Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
Responsibilities:
Writes procedures, investigations, protocols, reports, change
controls, etc. to support the Maintenance and Engineering, Validation,
Quality, and Regulatory departments.
Generates validation life cycle documentation (FAT, SAT, IOQ,
PQ) for cleaning, sterilization, shipping, and processes validation and
facilities, utilities, systems, equipment qualification/requalification.
Writes and revises a variety of Installation, Operation and
Performance qualification/verification related documents, including any of
all of the following: SOPs, validation/verification master plans, guidelines
and execution plans, automation test plans, engineering design reviews,
commissioning, qualification or other technical documents, user
requirement specifications (URS), functional requirement specifications
(FRS), detailed design specifications, factory acceptance test documents
(FAT), and/or commissioning test procedures.
Performs on site or support work for a client under supervision, including
but not limited to:
Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal
mapping of temperature controlled chambers, warehouses, and
sterilization processes
Equipment Qualification test execution
Investigations and deviations
Risk analysis, and/or
Data integrity assessments and review of client data
Executes protocols and helps resolve deviations/discrepancies,
analyze study data and write summary reports, under supervision of
senior consultants.
Qualifications and Experience:
Bachelors Degree in engineering, science, or similar field or equivalent experience; Preferred Education: Masters Degree in engineering, science, or similar field
2-8 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation
Experience with temperature mapping
Experience with many aspects of validation
Working knowledge of FDA and cGMP regulations and documentation practice
Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
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