Biopharmaceutical Commissioning and Qualification Engineer

3 weeks ago

Greenville, South Carolina, United States MMR Consulting Full time
Job Title: Biopharmaceutical Commissioning and Qualification Engineer

MMR Consulting is seeking a highly skilled Biopharmaceutical Commissioning and Qualification Engineer to join our team. As a key member of our engineering team, you will be responsible for commissioning, qualifying, and starting up bioprocess systems and equipment in the biopharmaceutical industry.

Key Responsibilities:
  • Provide technical guidance on commissioning, qualification, and start-up of various equipment and facilities.
  • Lead the development of key qualification deliverables during the project lifecycle to ensure project success.
  • Lead qualification processes throughout the project lifecycle, including VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ.
  • Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports.
  • Coordinate meetings with cross-functional departments to drive project progress and facilitate decisions.
  • Engage other departments as required for design reviews and decisions.
  • Travel may be occasionally required for meetings with clients, equipment fabrication vendors, or Factory Acceptance Testing (FATs).
  • Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases.
  • Client-management, project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development, and presenting at industry conferences/publishing papers.
  • Visit construction and installation sites following all site safety requirements.
  • Supervise contractors during critical testing of systems and equipment.
Requirements:
  • Excellent written and spoken English is required, including the preparation of technical documents in English.
  • Years of experience: 12+ years in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry, with minimum 6+ years of direct C&Q experience with upstream or downstream bioprocess equipment/systems.
  • Knowledge of requirements for cGMP operations, including SOPs, Change Controls, Validation.
  • Experience with developing and executing validation projects, Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
  • Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), is considered an asset.
  • Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
  • Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
  • Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
  • Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
  • Possess mentorship skills, to coach and develop junior and intermediate employees.
  • Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline.
  • Ability to handle multiple projects and work in a fast-paced environment.
  • Strong multi-tasking skills.

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 committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

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