MSAT Process Engineer II
About The Position
In this position, the ideal candidate would have strong background in assessing and processing quality events inclusive of deviations, CAPA plans and actions, and investigations. The candidate will support with guidance projects collaborating across multiple teams. The individual will possess strong partnership skills to build and maintain relationships. The individual will with guidance assess and execute projects to optimize existing and new processes, components, raw materials, and final product packaging. The individual will manage component, raw materials and packaging changes, replacements, and upgrades. The individual will support Procurement with response to supply shortage, helping to identify and implement alternatives. The individual will provide technical support and conduct investigations into product/process quality events. The individual will serve as a subject matter expert for aseptic processes and components and visual inspection. This position is based in Billerica, MA and requires a presence on-site, and open to applicants authorized to work for any employer within the United States.
Requirements
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical field (advanced degree preferred).
- 6+ years of experience in pharmaceutical manufacturing, with a strong focus on sterile injectable or radiopharmaceutical production.
- Solid understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485).
- Demonstrated ability to investigate deviations, problem solve, and execute changes within a quality system framework.
- Advanced technical writing skills required.
- Hands-on experience with equipment commonly used in sterile fill/finish operations.
- Familiarity with process validation, equipment qualification, and risk management principles.
- Self-starter with strong interpersonal and communication skills; able to work independently and in cross-functional teams.
- Proficiency in Excel, data analysis tools, and electronic document/change control systems (e.g., TrackWise, CATSWeb).
- Skilled at presenting technical content to technical and non-technical audiences.
- Expertise with GMP documentation requirements and awareness of requirements in a regulated environment.
- Work in cleanroom environments required.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.
- Candidate represents Lantheus to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism.
Nice To Haves
- advanced degree preferred
Responsibilities
- Provide day-to-day technical support to manufacturing operations, ensuring reliable production.
- Lead investigations for moderate- to high-complexity deviations, perform root cause analyses, and implement CAPAs in collaboration with QA and operations teams.
- Author and revise controlled documents, including manufacturing documentation, technical reports, protocols (e.g., process validation, equipment qualification), and risk assessments.
- Support process monitoring, trending, and data analysis activities to drive continuous improvement and maintain a state of control.
- Participate in cross-functional teams for process changes, equipment upgrades, and lifecycle projects, ensuring alignment with regulatory and quality requirements.
- Act as a technical contributor in change control execution, including impact assessments, protocol generation, and implementation planning.
- Support and/or lead multiple technical transfers, scale-ups, and process validation activities.
- Collaborate with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain to ensure timely and compliant execution of manufacturing campaigns.
- Ensure compliance with applicable regulations, including 21 CFR Parts 210, 211, 820, EU GMP Annex 1.
- Support readiness activities for internal and regulatory audits, including documentation review and SME participation.
- Actively demonstrates Lantheus’ values.
Benefits
- comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
- life and disability benefits
- pre-tax accounts
- a 401(k) with company contribution
- a variety of other benefits
- generous time off package including paid vacation, holidays, sick days, and paid parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
