Job Description

Job Description

Job Description

Salary:

Previous Pharmaceutical/Biotech experience is mandatory for this role.

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

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the clients facilities.

This role is for Bioprocess SR. C&Q Specialist role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior specialists.

We are looking for candidates for our clients in Raleigh-Durham-Chapel Hill Area and Boulder, Colorado.

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 to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and other specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.

• 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.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 12+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6+ years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
• 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.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: 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.
• Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• 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.
• Degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, Science 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

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