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Clark & Enersen · 2 months ago

CQV Engineer

Indianapolis, IN, US

Full-time

Hybrid

Entry, Mid Level

$80K/yr - $95K/yr

2+ years exp

Clark & Enersen is a leading global consulting firm in the life sciences sector, and they are seeking an experienced Validation Engineer to join their Indianapolis team. The Validation Engineer will be responsible for creating and managing validation documentation for cleanrooms and packaging equipment, ensuring compliance with regulatory standards.

Consulting

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

Qualification

Validation services experienceFDA regulations knowledgeCGMP documentation practiceTemperature mappingP&IDs interpretationBachelor's degreeSoft skills

Required

Bachelors Degree in engineering, science, or similar field or equivalent experience

2-5 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