Job Description Insight Global is looking to hire a Process SME sitting hybrid in Frederick or Gaithersburg, MD. This individual will ultimately be responsible for: - 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. Other Key Responsibilities Include: - 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. Compensation: $75.00/hr to $85.00/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements - 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 N/A