Pharma SME - Process

In this role, you will conduct field investigations and special studies for process/chemical design for large projects. You will lead the design, development, modification, and evaluation of components and processes used in process/chemical for projects with unique requirements. Your coordination will ensure that complex technical issues are resolved, clients are satisfied, and project needs are met.

• Plans, schedules, conducts, and coordinates process work for a global business unit delivering projects in Pharmaceutical Industry. Performs work that involves conventional engineering practice but may include solving complex design issues. Ability to support multiple projects as a subject matter expert.
• Review and provide design recommendations for new projects and proposed facility modifications to ensure conformance with relevant codes, standards and procedures.
• Assists in on-the-job training of assigned personnel and provides input for their performance evaluations.
• Prepares or assists in preparation of conceptual studies, designs, reports or proposals.
• Prepares and/or assists in the preparation of cost estimates, quantity take-offs and staffing requirements for proposals, forecasts and change orders.
• Reviews and checks work of subordinate engineers.
• Co-ordination with internal teams for the process related inputs / outputs.
• Plans and coordinates process deliverables for pharmaceutical projects ensuring compliance with code requirements.
• Supports the creation of a work environment that fosters openness, trust, communication, teamwork, empowerment, innovation, and satisfaction.
• Candidates should be able to demonstrate successful delivery of projects requiring strict regulatory compliance and detailed documentation control.

• 15+ years of relevant life sciences experience
• Experience on large capital projects
• Experience supporting GMP facility startup activities
• Experience in fast-track projects
• Experience with EPC, EPCM, Owner's Representative, or Contractor environments

Candidates should demonstrate the ability to work effectively with Owners, Engineering teams, Operations, Quality organizations, CQV organizations, Validation teams, Construction teams, Vendors and Regulatory representatives. The ability to coordinate multidisciplinary teams in regulated environments should be considered a core competency.

Candidates should also demonstrate experience with:

• Pharmaceutical process design
• API manufacturing processes
• Bioprocessing systems
• Process risk assessments
• Process flow diagrams (PFDs)
• P&IDs
• Process safety integration
• Process qualification support
• GMP facility startup support

Preferred experience:

• Process characterization
• Technology transfer
• Manufacturing process validation
• Cleaning validation awareness

Candidates should demonstrate experience supporting one or more of the following:

• Bulk API manufacturing facilities
• Oligonucleotide manufacturing facilities
• Sterile manufacturing facilities
• Biopharmaceutical manufacturing
• Secondary packaging facilities
• GMP laboratories
• QC and analytical laboratories
• Warehouse and cold-chain facilities supporting GMP operations
• Validated utility systems and infrastructure serving GMP facilities

Experience in regulated pharmaceutical, biotechnology, medical device, laboratory, healthcare, or life sciences environments are preferred.

Preferred Pharma candidates should possess a practical understanding of:

• Current Good Manufacturing Practice (cGMP)
• FDA 21 CFR Parts 210 and 211
• Good Documentation Practices (GDP)
• Change control processes
• Deviation management
• Risk-based quality management
• Inspection readiness
• Regulatory compliance expectations