Biopharmaceutical Commissioning Specialist

20 hours ago


Greenville, North Carolina, United States MMR Consulting Full time
Overview

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR's Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

Salary & Benefits

The estimated annual salary for this role is $120,000 - $180,000 depending on experience and qualifications.

Job Description

This is an outstanding opportunity to work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The successful candidate will be responsible for leading the development of key qualification deliverables during the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.

Responsibilities include:

  • Providing technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
  • Leading qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate.
  • Preparing protocols, executing protocols, summarizing data, resolving deviations, preparing final reports.
  • Cordinating meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
Required Skills & Qualifications

We are seeking an experienced C&Q Engineer with 8+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior engineers.

Requirements include:

  • Excellent written and spoken English is required including the preparation of technical documents in English.
  • Years of experience: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
  • Knowledge of requirements for a 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.


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