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Senior Biopharmaceutical Commissioning Engineer

2 months ago

San Diego, California, United States MMR Consulting Inc Full time

Essential experience in the Pharmaceutical/Biotech sector is required for this position.

MMR Consulting Inc. is a premier engineering and consulting organization focused on the pharmaceutical and biotechnology sectors. Our offerings encompass Engineering, Project Management, and various Consulting services. MMR's engineering proficiency spans Process, Automation, and Facilities engineering, while our pharmaceutical knowledge includes 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 role presents an exceptional opportunity for a skilled professional to engage with a team of engineers and specialists dedicated to project management, commissioning, and qualification of equipment, systems, and facilities. The successful candidate will be required to operate out of client facilities.

Position Overview

The position is aimed at a Bioprocess Commissioning and Qualification Engineer responsible for the commissioning, qualification, and startup of both upstream and downstream bioprocess systems and equipment within the biopharmaceutical sector, as well as process equipment in the pharmaceutical and biotech industries. The ideal candidate should demonstrate leadership capabilities to guide and mentor intermediate and junior engineers.

Key Responsibilities

  • Deliver technical direction for the commissioning, qualification, and initiation of various equipment and facilities.
  • Oversee the creation of essential qualification deliverables throughout the project lifecycle to ensure clarity and relevance of the action plan for system testing.
  • Manage 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.
  • Draft protocols, execute them, summarize findings, address deviations, and compile final reports.
  • Proven experience with C&Q of upstream or downstream bioprocess systems is mandatory. Familiarity with C&Q of other process equipment, utilities, and facilities is advantageous. Experience in Thermal Validation is also beneficial.
  • Facilitate meetings with cross-functional teams to advance project progress, support decision-making, and provide updates.
  • Collaborate with other departments as necessary for design evaluations and decisions.
  • Occasional travel may be required for client meetings, equipment fabrication vendors, or Factory Acceptance Testing (FATs).
  • Willingness to provide support during shutdowns or extended hours, particularly during installation and commissioning/validation phases.
  • Maintain key client relationships to support business development and the pursuit of new opportunities, manage project scheduling and budgeting, coordinate client and MMR resources for effective project delivery, and provide technical support for proposals.
  • Conduct site visits for construction and installation while adhering to all safety protocols.
  • Supervise contractors during critical system and equipment testing.
  • Perform additional duties as assigned by the client or MMR based on workload and project demands.

Qualifications

  • Proficient written and spoken English is essential, including the ability to prepare technical documentation in English.
  • Minimum of 8 years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry, with at least 6 years of direct C&Q experience with upstream or downstream bioprocess equipment/systems.
  • Comprehensive understanding of cGMP operations, including SOPs, Change Controls, and Validation.
  • Experience in developing and executing validation projects. Familiarity with Risk-Based Commissioning & Qualification methodologies, such as ASTM E-2500 or ISPE ICQ, is a plus but not mandatory.
  • Experience with commissioning and qualification of biotech process equipment (upstream or downstream) is required, including but not limited to fermentation, bioreactors, and downstream purification processes (chromatography, TFF, UF).
  • Experience with commissioning & qualification of process control systems (e.g., PCS, SCADA, Historians) and building automation systems (e.g., Siemens Insight / Desigo, JCI Metasys) is advantageous.
  • Experience with the qualification or validation of clean utilities, ISO clean rooms, and Thermal Validation is a plus.
  • Experience in preparing and executing URSs, DQs, 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 to help staff resolve issues.
  • Demonstrated leadership skills and initiative to manage projects involving multiple stakeholders and varying complexities.
  • Physical capability to lift 50 lbs.
  • Mentorship skills to coach and develop junior and intermediate employees.
  • Degree in Engineering or Science, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related field.
  • Ability to manage multiple projects and thrive in a fast-paced environment.
  • Strong multi-tasking abilities.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting Inc. is an equal opportunity employer. We celebrate diversity and are committed to fostering 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.