Job Title:
Automation Engineer SME
Overview:
Réalta Technologies seeks an experienced Automation Engineer SME to configure, validate, and program biopharma equipment. The ideal candidate will have hands-on experience in upstream and downstream manufacturing processes as well as Quality Control (QC) lab equipment.
o Configure and program biopharma manufacturing equipment used in both upstream and downstream processes, as well as QC lab and analytical equipment.
* Protocol Development & Documentation:
o 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), and Performance Qualifications (PQ).
* Validation Execution:
o Perform and oversee the execution of validation tests to ensure compliance with regulatory and industry standards.
* Authoring Procedures & SOPs:
o Develop and author detailed equipment administrative procedures and Standard Operating Procedures (SOPs) related to equipment configuration, calibration, and maintenance.
* Troubleshooting & Support:
o Provide manufacturing support by troubleshooting and resolving equipment-related issues that arise during production.
* Continuous Improvement & Compliance:
o Continuously review and improve existing procedures, ensuring the company remains compliant with the latest biopharma regulations and industry best practices.
Qualifications:
* Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, or a related field.
* Minimum 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:
o Proficiency in configuring and programming biopharma equipment.
o Strong documentation skills, especially related to URS, FDS, SDS, IQ, OQ, and PQ.
o Advanced troubleshooting skills in a manufacturing environment.