Overview:
Réalta Technologies is seeking a highly experienced Automation Engineer SME in the configuration, validation, and programming of biopharma equipment.
The ideal candidate will have hands-on experience across various upstream and downstream manufacturing processes as well as Quality Control (QC) lab equipment.
This SME will provide expert guidance to internal validation teams and lead the development and execution of validation protocols for computerized equipment.
The role also involves troubleshooting, manufacturing support, and equipment programming.
Key Responsibilities:
Biopharma Equipment ConfigurationConfigure and program biopharma manufacturing equipment used in both upstream and downstream processes, as well as QC lab and analytical equipment.
This includes but is not limited to:BioreactorsTFF SystemsChromatography SystemsBalancesFlow Instruments (FITs)Cell CountersParameterize equipment to meet the process specifications and standards.Protocol Development & DocumentationLead the preparation, review, and execution of critical documents such as:User Requirement Specifications (URS)Functional Design Specifications (FDS)System Design Specifications (SDS)Hardware Design Specifications (HDS)Installation Qualifications (IQ)Operational Qualifications (OQ)Performance Qualifications (PQ)Validation ExecutionPerform and oversee the execution of validation tests to ensure compliance with regulatory and industry standards.Collaborate with validation professionals to ensure alignment and clarity in the development of validation protocols.Authoring Procedures & SOPsDevelop and author detailed equipment administrative procedures and Standard Operating Procedures (SOPs) related to equipment configuration, calibration, and maintenance.Troubleshooting & SupportProvide manufacturing support by troubleshooting and resolving equipment-related issues that arise during production.Offer expert guidance on equipment malfunctions and recommend corrective actions.Continuous Improvement & ComplianceContinuously review and improve existing procedures, ensuring the company remains compliant with the latest biopharma regulations and industry best practices.Qualifications:
Education: Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, or related field.Experience:Minimum of 5-7 years' experience in configuring and validating biopharma manufacturing and QC lab equipment.Proven ability to lead and provide expert guidance on validation protocol development for computerized systems.Familiarity with regulatory requirements and standards (e.g., GAMP, cGMP, FDA, EMA).Technical Skills:Proficiency in configuring and programming biopharma equipment.Strong documentation skills, especially related to URS, FDS, SDS, IQ, OQ, and PQ.Advanced troubleshooting skills in a manufacturing environment.
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