Syner-G · 2 weeks ago
Process & Validation Engineer (100% Travel)
United States
Full-time
Onsite
Mid, Senior Level
4+ years expSyner-G is a biopharma product development and delivery partner dedicated to enhancing quality of life through innovative therapies. They are seeking a Process & Validation Engineer to assist with process engineering and validation protocols across various client sites, ensuring compliance with manufacturing and regulatory standards.
Health CareManufacturingPharmaceutical
No H1B
Responsibilities
Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit
Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE)
Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements
Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements
Provide technical support for the product/process lifecycle and related activities
Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed
Provide support for improvement projects regarding processes and systems
Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable
Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration)
Analyze and recommend improved technology to increase quality and efficiency
Provide technical analysis and support for new or improved process systems
Facilitate and schedule meetings with subject matter experts across the organization
Ensure compliance with cGMP, regulatory, and industry standards
Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification
Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR)
Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures
Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities
Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments
Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes
Support the resolution of regulatory observations or manufacturing site issues
Execute periodic reviews and requalification for temperature chambers
Qualification
Required
Bachelor's degree in Engineering, Bio/Pharma Science, or a related technical field of study
4-7 years of related engineering and/or technical experience required
Experience with cGMP Manufacturing within an FDA-regulated manufacturing company
Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company
Knowledge of FDA regulations and guidance or applicable regulatory standards and practices
Proficient with MS Office suite, MS Project, Visio, and related electronic formats required to perform the respective job at a client
Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc
Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer
Experience with Fillers, Wave Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and Flow Cytometers
Excellent computer, verbal, and written communication skills
Innovative problem-solving skills and an integrated view of business/scientific issues
Accountable and responsible individual to perform as intended for clients
Willingness to travel to various clients when needed, with acceptable limitations during noted health pandemics or related constraints
Bachelor's degree in a related life science field
4-7 years of experience within the biotech, pharmaceutical, or medical device industry
Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required
Validation expertise in Equipment, CSV, Method, and Process
Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation
Report writing experience for IQ, OQ, PQ, and CSV
Preferred
Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired
Benefits
Generous flexible paid time off program
Company paid holidays
Flexible working hours
Fully remote work options for most positions
The ability to work 'almost anywhere'
Company
Syner-G
Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ron Kraus
Chief Executive Officer
Prabu Nambiar
Founder, Strategic Advisor, Board Member
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