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Lead Validation Engineer

2 months ago

Albuquerque, New Mexico, United States curiate Full time
Job Overview

Senior Validation Engineer

Curia is a global leader in contract research and manufacturing services tailored for the pharmaceutical and biotechnology sectors.

The Senior Validation Engineer collaborates with Validation Contractors to support significant site projects and expansions. This role primarily focuses on the creation and implementation of validation and revalidation protocols for processes, equipment, utilities, and testing systems. The position works closely with the engineering and facilities teams to guarantee the correct installation and functionality of systems both prior to and following validation.

Key Responsibilities:
  • Design and implement validation and revalidation protocols for processes, equipment, utilities, and testing systems.
  • Draft and establish Standard Operating Procedures for new processes and equipment.
  • Assist engineering teams with ongoing projects through calibrations and validations.
  • Support internal and external audits by providing relevant data as required.
  • Keep management informed of validation-related issues that may impact regulatory compliance or financial outcomes.
  • Ensure adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDPs) in change controls, records, and procedures.
  • Review and compose validation protocols, final reports, and summaries for equipment release.
  • Participate in the assessment of validation protocols for computer systems, environmental monitoring, process validations, and cleaning validations.
  • Contribute to the evaluation of changes under the Change Control System from a validation standpoint.
  • Provide validation oversight for facility, utility, and equipment upgrades.
  • Offer validation insights during technology transfers.
  • Interpret and apply SOPs to ensure compliance.
  • Maintain current training records.
  • Perform additional duties as assigned.
Qualifications:
  • Bachelor's degree in Science, Engineering, or a related field.
  • A minimum of eight (8) years of relevant experience in pharmaceutical validation, particularly in aseptic or sterile product facilities.
  • Familiarity with FDA and EU regulations regarding pharmaceuticals and validation processes is preferred.
  • Experience with validation tools and methodologies is advantageous.
Language Proficiency:
The ideal candidate should be able to read and interpret various documents, including safety instructions, standard operating procedures, technical guidelines, and regulatory documents. Strong written and verbal communication skills are essential, along with effective presentation abilities.

Mathematical Proficiency:
Candidates must be proficient in performing arithmetic operations, including addition, subtraction, multiplication, and division across various units of measurement, utilizing whole numbers, fractions, decimals, and percentages. A solid understanding of algebraic and geometric principles is required.

Reasoning Skills:
Ability to identify problems, gather data, establish facts, and draw valid conclusions. Candidates should be capable of interpreting a wide range of technical instructions in both mathematical and diagrammatic forms, managing several abstract and concrete variables.

Technical Skills:
The ideal candidate will have a robust technical foundation and proven experience in effectively using various software tools to enhance organizational efficiency. Essential skills include proficiency in manufacturing and internet software, as well as Microsoft Office applications such as PowerPoint, Excel, Word, and Outlook.

Additional Skills:
  • Ability to mentor and guide team members.
  • Encourages a collaborative and positive work atmosphere.
  • Champions change initiatives.
  • Promotes a safe and healthy work environment by identifying and addressing potential hazards and adhering to safety protocols.
  • Exhibits strong attention to detail.
  • Demonstrates excellent communication skills, both verbal and written.
  • Possesses strong technical writing skills necessary for creating validation documentation.
  • Ability to work semi-independently while effectively collaborating with other technical departments.
  • Exceptional presentation and influencing skills, with the ability to engage and gain support from senior management.
  • Strong leadership and teamwork skills in a dynamic, cross-functional environment.
  • Ability to prioritize and manage multiple projects effectively.
  • Capable of reading, understanding, interpreting, and implementing technical documentation and instructions.
  • Effective interpersonal skills, maintaining adaptability to achieve organizational goals.
  • Clearly articulates ideas and information in a logical and concise manner.
Physical and Work Environment Requirements:
The physical demands of this role may vary, requiring regular or occasional lifting, pushing, and pulling of weights up to 10 pounds frequently, 25 pounds occasionally, and 50 pounds infrequently. Positions may require prolonged periods of sitting, standing, and reaching. Visual acuity, both near and far, is necessary, with or without corrective lenses. Employees must also demonstrate hand and finger dexterity for tasks ranging from typing to operating machinery.

The work environment may include office, manufacturing, or warehouse settings, each with specific characteristics. The office is designed for comfort, while the manufacturing environment is sterile, requiring aseptic gowning and personal protective equipment. The warehouse is typically temperature-controlled, with exposure to varying conditions.

Curia is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status. Curia is an E-Verify employer.