Commissioning, Qualification & Validation Consultant II
About The Position
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Requirements
- Requires master’s in engineering management or related field, or a foreign equivalent.
- 5 years of relevant experience in executing protocols including systems such as Process Validation, computer-controlled systems validation, utilities, manufacturing equipment such as computer-controlled filling systems, formulation systems.
Nice To Haves
- basic knowledge of laboratory validation
Responsibilities
- Develop Installation, Operational and Performance qualification documents.
- Preparing and executing validation documents for multiple systems.
- Execute protocols including complex systems such as process validation, medical devices, complex manufacturing equipment, formulation systems and basic knowledge of laboratory validation (not required but preferred).
- Will work in one or more validation subjects, such as laboratory equipment, temperature mapping, devices, process equipment, packaging equipment, cleaning, computers, HVAC or controls.
- Monitor and report on the execution of multiple validation tasks.
- Understanding the hours budgeted for completion of each task on a specific project.
- Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management, and peers.
- Ability to make suggestions to clients on future needs and assessments
- Interpretation of 21 CFR Part 11, 210, 211, and 820 as well as understanding of FDA cGMPs, FDA Guidelines and European Guidelines (where applicable).
- Travel is required.
- Other duties as assigned.
Benefits
- This position is eligible for a referral bonus under the Global Employee Referral Program Policy.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
