Biopharmaceutical Commissioning & Qualification Specialist
| Company | MMR Consulting |
|---|---|
| Location | Greenville, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Previous Pharmaceutical/Biotech experience is mandatory
- 8+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry
- 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
- Excellent written and spoken English is required including the preparation of technical documents in English
- Degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, Science or a related discipline
Responsibilities
- Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities
- Lead the development of key qualification deliverables during the project lifecycle
- Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate
- Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports
- Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates
- 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 (maintain key Client relationships in support of business development and pursuit of new work)
- Project scheduling/budgeting, coordination of client and MMR resources for effective project delivery
- Supporting business development (providing technical support to the sales as required for proposals/opportunities)
- Presenting at industry conferences/publishing papers etc.
- Visit construction and installation sites following all site safety requirements
- Supervise contractors during critical testing of systems and equipment
- Other duties as assigned by client, and/or MMR, based on workload and project requirements
Preferred Qualifications
- Experience with C&Q parts washer and autoclave is required
- Experience with C&Q of other process equipment, utilities, facilities is an asset
- Thermal Validation experience is an asset
- 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)
- 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
- Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports
- Possess mentorship skills, to coach and develop junior and intermediate employees
- Ability to handle multiple projects and work in a fast-paced environment
- Strong multi-tasking skills