Overview
Réalta Technologies seeks 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.
Key Responsibilities
* Biopharma Equipment Configuration
* Configure 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:
* Bioreactors
* TFF Systems
* Chromatography Systems
* Balances
* Flow Instruments (FITs)
* Cell Counters
* Parameterize equipment to meet the process specifications and standards.
* Protocol Development & Documentation
* Lead 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 Execution
* Perform 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 & SOPs
* Develop and author detailed equipment administrative procedures and Standard Operating Procedures (SOPs) related to equipment configuration, calibration, and maintenance.
* Troubleshooting & Support
* Provide 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 & Compliance
* Continuously 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.