Insight Global · 6 days ago
Process Engineering Consultant (Pharma)
Gaithersburg, MD
Contract
Hybrid
Senior Level
$83/hr - $101/hrInsight Global is looking to hire a Process SME sitting hybrid in Frederick or Gaithersburg, MD. This individual will ultimately be responsible for providing technical direction and leadership for specification, design, supplier selection, and delivery of critical technical packages in line with AZ requirements, while ensuring technical governance throughout the project lifecycle.
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Responsibilities
Provide technical direction and leadership for specification, design, supplier selection, and delivery of critical technical packages in line with AZ requirements
Ensure technical governance throughout the project lifecycle
Support the receiving AZ organization during start-up and early operations to meet performance criteria
Govern design, specification, performance, and commissioning & qualification of assigned packages while owning and championing operational lifecycle considerations, including material and waste movement, ancillary room and equipment specifications, maintenance and calibration access, and total lifecycle cost versus capital cost
Design Support: Provide technical input for Concept, Basic, and Detailed Design stages
Information Sharing: Gather and communicate company processes and technical data to contractors and suppliers
Standards & Requirements: Define company standards and performance expectations; translate into technical requirements
Supplier Assessment: Evaluate critical equipment suppliers and recommend selections
Handover: Ensure complete and accurate handover documentation
Design Development: Work with contractors to convert company requirements into engineering deliverables
Design Assurance: Conduct reviews, issue reports, and identify value engineering opportunities
Compliance: Ensure SHE and GMP requirements are embedded in all design deliverables
Stakeholder Engagement: Align design with company stakeholder needs and expectations
Risk Management: Participate in SHE risk assessments and implement mitigations
Procurement: Support strategy, contractor selection, and technical scope definition
User Requirement Specification (URS) Ownership: Ensure URSs are complete, accurate, and approved on time
Equipment Review: Validate datasheets, RFPs, and interface alignment; confirm operating parameters for IT/digital twin
P&ID Development: Support creation of P&IDs for early execution modules
Technical Guidance: Coach project teams and ensure solutions meet cost and schedule goals
Commissioning & Qualification: Support C&Q activities; review and approve FAT, SAT, DQ, IQ, and OQ protocols
Approvals: Authorize equipment release and commissioning per CPDP stage gates
Issue Resolution: Provide tactical advice during design and execution phases
Operational Support: Assist with hypercare, process qualification, and establishment batches
Continuous Improvement: Capture lessons learned and refine CPDP best practices
Qualification
Required
Deep expertise in pharmaceutical process design and technical packages for sterile/biotech facilities
Proven ability to lead specification, design, supplier selection, and delivery of critical process equipment (e.g., bioreactors, TFF systems, ancillary rooms, material flow)
Strong knowledge of GMP, GEP, SHE compliance and lifecycle cost considerations
Experience developing and approving URS, P&IDs, datasheets, and design assurance reports
Hands-on involvement in commissioning & qualification (FAT, SAT, DQ, IQ, OQ) and stage-gate approvals
Ability to translate customer requirements into engineering deliverables and ensure digital/data readiness
Skilled in stakeholder engagement and technical governance throughout concept, design, and execution phases
Strong collaboration and leadership skills to guide project engineering teams and suppliers
Company
Insight Global
Insight Global provides top talent and staffing solutions that help job seekers find careers in healthcare, finance, IT, and government.
Founded in 2001
1001-5000 employees
H1B Sponsorship
Insight Global has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (281)
2024 (164)
2023 (75)
2022 (17)
2021 (3)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2010-07-01Acquired
Leadership Team
Jared Streppa
President Of Company’s Technology Division
Recent News
Maryland Daily Record
2025-09-26
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