Syner-G BioPharma Group

Engineer

• Perform startup and commissioning of building and utility systems such as HVAC, chilled water, water systems, electrical systems, fire protection, pH neutralization, and waste systems.
• Generate and manage engineering lifecycle documentation, including impact assessments, URS/FRS documents, FAT/SAT documentation, ETOPs, and P&IDs.
• Conduct drawing walkdowns and verify field installation of equipment and utilities.
• Develop and execute commissioning protocols and reports.
• Support troubleshooting and issue resolution during commissioning and startup activities.
• Utilize systems such as BMS, PCS, and CMMS; experience with KNEAT is a plus.
• Coordinate with cross‑functional teams including engineering, facilities, operations, and quality to support project deliverables.

Senior Project Engineer

• Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
• Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
• Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• Prepare summary reports for validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Perform P&ID walkdowns to verify installation and system readiness.
• Conduct thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Perform periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.

Validation Engineer

Manager

• Translate information provided by managers or SMEs into audience-friendly slide decks
• Convert videos, workflows, or process steps into clear written guides or reference materials
• Assist in building training content as senior team members explain upcoming changes
• Follow established templates, branding, and instructional guidelines
• Support the deployment of training materials and track completion or feedback
• Make updates or edits to training content based on manager direction
• Assist with basic change impact assessments by gathering and organizing information
• Help prepare communications drafted by senior team members
• Support readiness activities such as scheduling sessions, preparing materials, and maintaining trackers
• Document stakeholder feedback and share with the manager for review
• Work with engineering, operations, and project teams to collect information needed for training materials
• Participate in meetings to capture notes and action items related to training or change activities
• Clarify content needs with SMEs under the guidance of a senior team member
• Maintain organized repositories of training materials and version histories
• Support inspection or audit readiness by gathering required documentation
• Assist with tracking timelines, deliverables, and review cycles

Organizational Change Manager

• Lead one or more sub-work streams amongst the different components of Organizational Change Management (OCM) – Change Readiness, Training & Communications.
• Apply a structured methodology and lead change management activities.
• Leverage a change management methodology, process, and tools to create an executable plan to support adoption of the changes required by a project or initiative.
• Enable the design, development, delivery, and management of key project-related communications to be distributed across an organization’s impacted stakeholders, customers, and suppliers.
• Conduct impact analyses, assess change readiness, identify key stakeholders, and create executable actions meant to support adoption of the changes identified.
• Independently assess training needs and determine appropriate learning strategies and modalities, including PowerPoint-based training, e-learning modules, reference guides, and other instructional formats.
• Partner with stakeholders to identify, scope, and build out training content aligned with project and organizational needs.
• Create training content and, when required, deliver training directly to end users or stakeholder groups.
• Deploy training programs, monitor effectiveness, and make updates or modifications as needed.
• Plan, manage, and support the design and delivery of training programs for end users and customers/suppliers.
• Apply behavioral tools to assess the impact of change on organizations, using assessments of organizational culture, performance, and readiness for change.
• Prepare comprehensive change and workforce transition plans and programs, including strategies to support change and transition initiatives and engage leadership.
• Drive work efforts and leverage data-driven solutions to deliver change outcomes and measure the impacts on end users.
• Enhance user experience by improving adoption, usability, accessibility, and interactivity of solutions.
• Provide coaching and/or mentoring of team members.

Senior Project Engineer

Validation Engineer

Organizational Change Manager

Senior Program Organizational Change Manager