Process Engineer II
Process Engineer II
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Salary Not Disclosed
1 Vacancy
Job Description
Lantheus is headquartered in Bedford Massachusetts with offices in Canada and Sweden. For more than 60 years Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial agile growing organization that provides innovative diagnostics targeted therapeutics and artificial intelligence (AI) solutions that empower clinicians to find fight and follow Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someones health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
This position site-based and requires a presence on-site three days per week.
Position Summary:
We are seeking an experienced and driven Process Engineer II to support commercial and clinical manufacturing of radiopharmaceutical drug products. This position plays a critical role in ensuring robust compliant and efficient production processes for sterile injectable and device-combination products. The ideal candidate brings 6 years of hands-on experience in cGMP manufacturing support with a strong understanding of sterile drug production radiopharmaceutical workflows and medical device quality systems.
Key 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 PartsEU GMP Annex 1 and radiation safety requirements.
- Support readiness activities for internal and regulatory audits including documentation review and SME participation.
Qualifications:
- Bachelors 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.
Preferred Experience:
- Experience in handling radioactive materials or supporting radiopharmaceutical manufacturing environments.
- Knowledge of lean manufacturing principles and process improvement methodologies.
- Experience in lifecycle management of commercially approved pharmaceutical products and devices.
- Experience in managing large cross-functional projects in a matrix environment.
Work Environment & Physical Requirements:
- Work in cleanroom environments and radiation-controlled areas required.
- Some off-shift or weekend coverage may be needed based on production schedules.
Core Values
The ideal candidate will embody Lantheus core values:
- Let people be their best
- Respect one another and act as one
- Learn adapt and win
- Know someones health is in our hands
- Own the solution and make it happen
Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any other characteristic protected by law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .
Employment Type
Full-Time
