Senior Process Development Scientist - Process Engineer

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Job description

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

Job Title:

Senior Process Development Scientist Process Engineer

Current Locations:

Portsmouth, NH

Position Description

AM is looking for a Process Development Scientist to join our organization to support manufacturing processes for a GMP facility. The engineer will act as the primary technical support person for manufacturing processes. They will be responsible for performing all functions associated with process transfer and process support including; develop process understanding, perform gap analysis/FMEA, generate process models, author/review Process Descriptions and Batch Records, author/review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes). This engineer will also be expected to recommend improvements for MSAT practices and procedures and may be asked to provide guidance on process transfer and support activities to junior members of the team.

Direct Involvement Opportunities:

• Performs all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis/FMEA, generate process models, author/review Process Descriptions and Batch Records, author/review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes).
• Assess all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products.
• Identifies potential Root causes using a systematic approach. Expertise in use/application of a variety of problem-solving tools e.g. Fishbone, Kepner-Tregoe, etc.
• Performs and is able to understand and interpret complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications where appropriate.
• Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates.
• Identifies and creates new documents that would aid in process transfer or support activities.
• Identifies process changes and assesses change controls for impact of process/equipment or procedural changes that can affect both process performance and product quality.
• Supports documentation preparation for regulatory purposes.
• Represents MSAT on project teams and interfaces with customer technical and quality representatives.
• Represents MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings).
• Participates in Customer and Regulatory Audits.
• Regularly interacts with site leadership on matters concerning several functional areas, divisions, and/or customers.

Qualifications, Skills, And Experience:

• Bachelors degree or equivalent in Engineering, Science, or related discipline
• 9+ years of biotech industry experience (5+ years for Ph.D.) in process development and process scale-up/manufacturing.
• Experience with large-scale manufacturing support (mammalian preferred).
• Thorough knowledge of cGMPs, EU/ICH, and global regulatory requirements.
• Strong organizational, interpersonal, and communication skills to plan and accomplish goals.
• Team-oriented approach to project management and problem resolution.

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