ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health cha…
Skills: Validation engineering, FAT/SAT, IQ/OQ/PQ, Cleanroom qualification, Process validation
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Registered Nurse (RN) - Wound Care - North Clinic -
Indianapolis, Indiana, United States · On-site
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Anew Home Heath is now hiring an Occupational Therapist! PRN hours available! This position will cover the Fishers, IN area. Candidate MUST be a licensed Occupational Therapist. Anew Home Health is a local family-owned c…
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$80k–$95k/yr
Full-time
bachelor degree
Health insurance, Dental insurance, Vision insurance, Life insurance, 401(k) plan with employer match, Paid time off
Posted 4d ago
~40 hrs/week
Responsibilities
The Validation Engineer is responsible for creating and executing validation documentation for cleanrooms, utilities, and packaging equipment. They will perform protocol execution, manage deviations, and ensure compliance with FDA and cGMP regulatory standards.
Requirements
Candidates must hold a Bachelor's degree in engineering or science and possess 2-5 years of experience in a regulated manufacturing environment. Proficiency in validation protocols, temperature mapping, and regulatory documentation practices is required.
Full job description
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
We at Eliquent are looking for an experienced Validation Engineer to immediately join our Eliquent Consulting: Indianapolis team. The Validation Engineer is an FTE project based role. The Validation Engineer is responsible for the theory and content of validation documents for new cleanrooms and packaging equipment, including utilities qualification, cleanroom qualification, and FAT/SAT/IQ/OQ/PQ of a new packaging line. This will ensure that validation documentation is compliant with site and corporate validation requirements and policies as well as compendial (e.g., USP) and regulatory (e.g., FDA) expectations/regulations.
ESSENTIAL DUTIES AND 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 REQUIREMENTS:
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
What We Offer:
Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products.
Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape.
From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust.
Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges.
Learn more at ELIQUENT.com
How many Healthcare jobs are open in Indianapolis, IN right now?
There are currently 3,606 open healthcare positions in Indianapolis, IN listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Indianapolis, IN?
Companies currently hiring include Indiana University Health, Ascension, Eli Lilly and Company, Franciscan Health, Health & Hospital Corporation of Marion County, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Indianapolis, IN?
Yes — 481 of the 3606 open healthcare positions offer remote or hybrid work (170 remote, 311 hybrid).
How do I apply for Healthcare jobs in Indianapolis, IN?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.