Katalyst CRO ยท 1 day ago
Manufacturing Engineer III
Andover, MA
Full-time
Onsite
Senior Level
7+ years expKatalyst CRO is a confidential company seeking a Manufacturing Engineer III to lead the development and execution of validation master plans and protocols. The role involves ensuring manufacturing readiness, regulatory compliance, and supporting cross-functional project teams while adhering to FDA and ISO standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead the development, execution, and approval of validation master plans, validation plans, IQ/OQ/PQ protocols, and final reports, with emphasis on sterilization, endotoxin control, and microbiology-related processes
Support process design transfer activities, ensuring manufacturing readiness and regulatory compliance
Perform statistical analysis to support validation data, conclusions, and technical reports
Develop and implement change controls, engineering change orders (ECOs), and engineering notices
Create statistically justified sampling plans for in-process controls, final inspections, and validation activities
Troubleshoot equipment and manufacturing processes that fail to perform as expected during validation or production runs
Identify and recommend process and quality improvements based on validation outcomes and operational feedback
Investigate, document, and resolve nonconformances, protocol deviations, and CAPA activities, including authoring investigation reports
Serve as a key contributor on cross-functional project teams, collaborating with Manufacturing, Engineering, Quality, Regulatory, Facilities, Microbiology, suppliers, and external partners
Ensure all activities comply with FDA, ISO, GMP, OSHA, EPA, and applicable international regulatory standards. Support the preparation and review of technical documentation for domestic and international regulatory submissions
Participate in and support external audits and inspections, including FDA, Notified Bodies (e.g., BSI), and corporate audits
Perform additional duties as required to support manufacturing and quality objectives
Qualification
Required
Lead the development, execution, and approval of validation master plans, validation plans, IQ/OQ/PQ protocols, and final reports, with emphasis on sterilization, endotoxin control, and microbiology-related processes
Support process design transfer activities, ensuring manufacturing readiness and regulatory compliance
Perform statistical analysis to support validation data, conclusions, and technical reports
Develop and implement change controls, engineering change orders (ECOs), and engineering notices
Create statistically justified sampling plans for in-process controls, final inspections, and validation activities
Troubleshoot equipment and manufacturing processes that fail to perform as expected during validation or production runs
Identify and recommend process and quality improvements based on validation outcomes and operational feedback
Investigate, document, and resolve nonconformances, protocol deviations, and CAPA activities, including authoring investigation reports
Serve as a key contributor on cross-functional project teams, collaborating with Manufacturing, Engineering, Quality, Regulatory, Facilities, Microbiology, suppliers, and external partners
Ensure all activities comply with FDA, ISO, GMP, OSHA, EPA, and applicable international regulatory standards
Support the preparation and review of technical documentation for domestic and international regulatory submissions
Participate in and support external audits and inspections, including FDA, Notified Bodies (e.g., BSI), and corporate audits
Perform additional duties as required to support manufacturing and quality objectives
Strong working knowledge of FDA, ISO, GMP, OSHA, and EPA regulations
Demonstrated experience with risk management, CAPA, and continuous improvement methodologies
Proven project management skills, including the ability to lead complex, cross-functional initiatives
Ability to provide technical leadership and guide teams through challenging manufacturing and validation activities
Excellent written and verbal communication skills with a history of effective cross-functional collaboration
Strategic thinker with strong problem-solving and decision-making abilities
Hands-on experience authoring and maintaining technical documentation, including: Validation plans and protocols, Change controls and ECOs, Investigation and technical reports, SOPs and work instructions
Bachelor's degree in Engineering or Science, preferably Mechanical, Industrial, Electrical, Chemical, Biomedical, or a related discipline
Demonstrated experience in validation of manufacturing equipment, processes, stability, or aging studies
Minimum of 7+ years of experience in a medical device and/or pharmaceutical manufacturing environment
Preferred
Lean / Six Sigma Green Belt or Black Belt certification preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase