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X4 Life SciencesNew Hampshire, United States, United States
9 days ago
Job type
Full-time
Job description
Senior Process Engineer
A global biopharma company is seeking a Senior Process Engineer for their facility in New Hampshire. This role offers a comprehensive relocation package and involves supporting manufacturing operations, and equipment troubleshooting to ensure the smooth and continuous production of critical biopharmaceutical products.
Key Responsibilities :
Lead troubleshooting and corrective actions to resolve issues in manufacturing processes, ensuring uninterrupted product supply.
Serve as the system owner for manufacturing equipment and utilities, ensuring compliance with industry standards and maintaining lifecycle documentation.
Design, implement, and validate manufacturing systems, including facilities, utilities, and instrumentation from lab scale to full manufacturing scale.
Lead the development and execution of engineering documents, including specifications, user requirements, and qualification protocols.
Manage projects, including planning, resource allocation, budgeting, and timeline management for new equipment and systems.
Drive continuous process improvements, automation changes, and system upgrades to enhance manufacturing efficiency and reduce downtime.
Act as the technical point of contact during regulatory inspections and audits, ensuring compliance with cGMP, GEP, GAMP, and other regulatory standards.
Mentor and develop junior engineers while contributing to the strategic growth of the engineering team.
Qualifications :
Bachelor's or Master's degree in Engineering or a related life sciences discipline.
8-10+ years of experience in the pharmaceutical or biotechnology industry, with strong knowledge of process engineering in cGMP environments.
Expertise in GEP, GAMP, validation, and regulatory requirements in a biopharmaceutical setting.
Experience leading cross-functional teams, project management, and managing engineering life cycle documentation.
Strong analytical and problem-solving skills, with the ability to make independent decisions based on data and risk assessments.
Willingness to provide support outside of regular hours, including nights and weekends, as needed for manufacturing support.
If you're interested in this exciting opportunity or would like more information, please apply and reach out directly to [email protected] .
Will be great to run through the role in details with you!
Alternatively, if you are not interested, but know someone who is, please share with them.