Biopharmaceutical - Csv Engineer

**Biopharmaceutical - CSV Engineer**

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and Validation. MMR has offices in Canada, USA, Australia, India and Singapore.

Previous Pharmaceutical/Biotech experience is mandatory for this role.

**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.
- 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.
- Supervise contractors during critical testing of systems and equipment.
- Other duties as assigned by client, and/or MMR, based on workload and project requirements.

**Organization activities**
- Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc. for any new or change induced validation system / activities.
- Good fundamental technical knowledge of automation system such as Siemens PCS7, OSIPI or IT system to assist automation engineers in developing life cycle documentation.
- Independently schedule, organize and coordinate at detailed site level, validation activities with cross functional groups
**Documentational activities**
- Assist in raising Change Control to update Automation System Life cycle documentation, SOPs, Risk Assessment, Requirement Traceability Matrix etc.Review and approve of validation protocols, reports and deliverables for the specialized validation area.
- Review and approve of validation protocols, reports and deliverables for the specialized validation area.
- Define requirements for validation activities and ensure regulatory compliance based on Risk Assessment.
- Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier.
- Review and check documentation for GMP compliance.
- Collaboration and or Creation of Validation summaries.

**Engineering**
- Troubleshoot and evaluate equipment or system excursions based on validated status or change controls

**Qualifications**
- Excellent written and spoken English is required including the preparation of technical documents in English.
- Years of experience: 4+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry. OR 5 years in a related regulated environment.
- Knowledge of requirements for a cGMP operation, 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, but not required.
- Thermal Validation experience is considered an asset.
- Experience with commissioning and qualification of process equipment for aseptic fill-finish and pharmaceutical API and OSD processes are considered an asset.
- Experience with commissioning & qualification of process control systems (i.e. Emerson Delta-V, Siemens PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
- Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
- Knowledgeable in GAMP5, ANSI/ISA-88 and 21 CFR PART 11 requirements.
- Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
- 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 Biological/Pharmaceutical science or engineering sciences. Equivalent degree or experience possible.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills.