Astellas Pharma · 1 week ago
Process Engineer
Sanford, NC
Full-time
Hybrid
Entry, Mid Level
$91K/yr - $143K/yr
2+ years expAstellas Pharma Inc. is a pharmaceutical company committed to developing innovative therapies for patients. The Process Engineer will provide technical support for the deployment of new equipment and processes, troubleshoot existing systems, and collaborate with various teams to enhance drug substance manufacturing.
BiotechnologyHealth CareMedical
Responsibilities
Provide process engineering, design, and on-going improvements for drug substance manufacturing processes
Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities
Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization
Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners
Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate
Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation
Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements
Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports
Support/lead tech transfer, equipment commissioning, training, and validation activities
Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing
Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems
Support process deviation investigations, root cause analysis, and CAPAs
Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction
Will support and demonstrate data integrity standards to ensure data of highest quality
Qualification
Required
MS in Engineering or Life Sciences, entry level, or BS with 2 years of relevant technical experience
Sound technical knowledge of upstream or downstream bioprocessing with a background in biologic or ATMP process development, technical transfer, and/or manufacturing
Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers
Ability to think critically, and demonstrated troubleshooting and problem-solving skills
Demonstrated experience with interpreting complex data sets
Effective scientific communication skills, including technical writing and presentation of technical content to diverse audiences
Capable of working independently with minimal supervision
Desire to work within a fast-paced environment under challenging timelines
Attention to detail supported by good time management and organizational skills
Proficiency with MS Office (Excel, PowerPoint, Word, Project, and Visio)
Preferred
Experience in gene therapy and/or monoclonal antibody manufacturing, scale-up/scale-down, and tech transfer
Understanding of industry expectations with respect to phase appropriate requirements while advancing products from pre-clinical to commercial state
Experience with statistical analysis and associated software (e.g., JMP)
Experience with single-use equipment and systems
Knowledge of cGMPs and good documentation practices (GDP)
Experience with process equipment and facility design engineering such as hydraulic calculations, equipment sizing, process simulations, Heat and Material Balances (H&MB), Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), and User Requirement Specification (URS) development
Experience with process validation and lifecycle management
Experience supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma 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 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase