Biopharmaceutical Commissioning Specialist

2 weeks ago

Austin, Texas, United States MMR Consulting Full time
Job Overview

Position: Biopharmaceutical Commissioning & Qualification Engineer

Salary: Competitive

Experience Required: Previous experience in the Pharmaceutical or Biotechnology sectors is essential for this position.

MMR Consulting is a premier engineering and advisory firm dedicated to the pharmaceutical and biotechnology sectors. Our expertise encompasses Engineering, Project Management, and various Consulting services. We specialize in Process, Automation, and Facilities engineering, with a focus on Oral Solid Dosage, Semi-Solids, Liquid-Dosage (both Terminal Sterilization and Aseptic), API manufacturing, and Biotechnology (including Vaccines, Blood Plasma Fractions, and Monoclonal Antibodies).

This is an exceptional opportunity to become part of our expanding team. The successful candidate will collaborate with a group of engineers and specialists engaged in project management, commissioning, and qualification of equipment, systems, and facilities. The role will involve working at client facilities.

Key Responsibilities:

  • Provide expert guidance in the commissioning, qualification, and initiation of various equipment and facilities.
  • Lead the creation of critical qualification deliverables throughout the project lifecycle to ensure clarity and relevance of the action plan for system testing.
  • Implement qualification processes during the project lifecycle, including VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ, ensuring timely completion and adherence to quality and engineering standards.
  • Prepare and execute protocols, summarize findings, address deviations, and compile final reports.
  • Demonstrate experience with the commissioning and qualification of process equipment, utilities, and facilities, including Analytical Instruments, Clean Gas Utilities, Purified Water, Water For Injection, Process Chromatography Systems, Bioreactors, and Graded Rooms.
  • Facilitate meetings with cross-functional teams to advance project timelines, support decision-making, and provide updates.
  • Engage with other departments as necessary for design reviews and critical decisions.
  • Be available for occasional support during shutdowns or extended hours, particularly during installation and commissioning/validation phases.
  • Oversee contractors during essential testing of systems and equipment.
  • Perform additional duties as assigned by the client or MMR, based on project demands.

Qualifications:

  • Proficient in written and spoken English, with the ability to prepare technical documentation in English.
  • A minimum of 6 years of experience in commissioning, qualification, or validation of systems within the pharmaceutical or biotech industry.
  • Understanding of cGMP operations, including SOPs, Change Controls, and Validation requirements.
  • Experience in developing and executing validation projects. Familiarity with Risk-Based Commissioning & Qualification methodologies, such as ASTM E-2500 or ISPE ICQ, is advantageous.
  • Knowledge of commissioning and qualification of process control systems (e.g., PCS, SCADA, Historians) and building automation systems (e.g., Siemens Insight / Desigo, JCI Metasys) is a plus.
  • Experience with the qualification or validation of clean utilities, ISO clean rooms, and Thermal Validation.
  • Familiarity with KNEAT is preferred.
  • Experience in preparing and executing URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, and Final Reports.
  • Ability to lead teams of Validation staff, manage priorities, and provide mentorship and oversight.
  • Possess strong leadership skills and the initiative to lead projects involving multiple stakeholders and varying complexities.
  • A degree in Engineering or Science, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related field.
  • Capable of managing multiple projects in a fast-paced environment.
  • Strong multi-tasking abilities.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are dedicated to working with and providing reasonable accommodations to individuals with disabilities globally. If you require a reasonable accommodation for any part of the application or interview process due to a medical condition or disability, please inform us of your request.

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