BW Design Group
Process Engineer - Oral Solid Dosage (Contract)
BW Design Group, Boston, Massachusetts, us, 02298
Process Engineer - Oral Solid Dosage (Contract)
Join to apply for the Process Engineer - Oral Solid Dosage (Contract) role at BW Design Group.
What You’ll Do
Manage process mechanical design for the manufacturing of sterile products in the pharmaceutical, biological, and medical device industries
Assist with the design of Oral Solid Dosage manufacturing facilities
Assume responsibility for all phases of project execution including concept/strategic planning, engineering design, construction, and turnover to validation in the execution of EPCMV projects
Execute a wide range of projects including system enhancements/unit operation optimization and greenfield construction
Ensure that manufacturing, facilities and maintenance, quality, and validation systems are designed in accordance with current Good Manufacturing Practices
Develop process flow diagrams (PFDs), prepare energy and mass balance calculations, and conduct cycle time, bottleneck, and gap analyses
Handle equipment selection, sizing, and specifications, and create utility requirement matrices
Develop process construction documents including piping & instrument diagrams (P&IDs) and equipment general arrangement drawings
Create piping plans including orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie-in lists, installation specifications, bills of material (BOM), and scopes of work
Direct the work performed by CAD designers
Facilitate design coordination with controls/automation systems, utilities systems, and building systems
Provide on‑site support during system installation, testing, start‑up, commissioning, and qualification
Develop project scopes and assist with preparation of proposals for engineering/design services
Keep abreast of new and emerging technologies and current Good Manufacturing Practices
Make an impact day‑to‑day with your skills and expertise, strengthening that relationship with our clients and team
What You’ll Bring
A minimum of three years of relevant biologics, pharmaceutical, biotechnology, or medical device process system engineering/design experience
Design experience in upstream/downstream processes, single use systems, CIP/SIP, support equipment (washers, autoclaves, lyophilizers), and high purity water systems (WFI, RODI)
Experience in the design, installation, and startup of traditional bioprocess equipment, GXP utility systems, or field supervision of trades during construction and commissioning
Experience with the design of Oral Solid Dosage manufacturing facilities
A working knowledge of process definition means and methods including identifying process unit operations
An understanding of FDA and EMA regulatory standards
A familiarity with process control methodologies and control valves and instrumentation
Experience developing functional specifications
Excellent written and verbal communication skills and the ability to successfully interact with our team members and clients
Proficiency in AutoCAD (basic), Microsoft Office, and Microsoft Project (basic)
Familiarity with 3D modeling, computer-based hydraulic analysis, and process simulation software (preferred)
A willingness to travel for project requirements including installation and start‑up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions
A bachelor of science in chemical or mechanical engineering, bioengineering, or a similar engineering degree with applicable life science industry, consulting, or project experience
About the Team Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. As a Process Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools.
Pay Range The approximate pay range for this position is $50 - $100 per hour. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.
Seniority level Associate
Employment type Contract
Job function Management and Manufacturing
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What You’ll Do
Manage process mechanical design for the manufacturing of sterile products in the pharmaceutical, biological, and medical device industries
Assist with the design of Oral Solid Dosage manufacturing facilities
Assume responsibility for all phases of project execution including concept/strategic planning, engineering design, construction, and turnover to validation in the execution of EPCMV projects
Execute a wide range of projects including system enhancements/unit operation optimization and greenfield construction
Ensure that manufacturing, facilities and maintenance, quality, and validation systems are designed in accordance with current Good Manufacturing Practices
Develop process flow diagrams (PFDs), prepare energy and mass balance calculations, and conduct cycle time, bottleneck, and gap analyses
Handle equipment selection, sizing, and specifications, and create utility requirement matrices
Develop process construction documents including piping & instrument diagrams (P&IDs) and equipment general arrangement drawings
Create piping plans including orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie-in lists, installation specifications, bills of material (BOM), and scopes of work
Direct the work performed by CAD designers
Facilitate design coordination with controls/automation systems, utilities systems, and building systems
Provide on‑site support during system installation, testing, start‑up, commissioning, and qualification
Develop project scopes and assist with preparation of proposals for engineering/design services
Keep abreast of new and emerging technologies and current Good Manufacturing Practices
Make an impact day‑to‑day with your skills and expertise, strengthening that relationship with our clients and team
What You’ll Bring
A minimum of three years of relevant biologics, pharmaceutical, biotechnology, or medical device process system engineering/design experience
Design experience in upstream/downstream processes, single use systems, CIP/SIP, support equipment (washers, autoclaves, lyophilizers), and high purity water systems (WFI, RODI)
Experience in the design, installation, and startup of traditional bioprocess equipment, GXP utility systems, or field supervision of trades during construction and commissioning
Experience with the design of Oral Solid Dosage manufacturing facilities
A working knowledge of process definition means and methods including identifying process unit operations
An understanding of FDA and EMA regulatory standards
A familiarity with process control methodologies and control valves and instrumentation
Experience developing functional specifications
Excellent written and verbal communication skills and the ability to successfully interact with our team members and clients
Proficiency in AutoCAD (basic), Microsoft Office, and Microsoft Project (basic)
Familiarity with 3D modeling, computer-based hydraulic analysis, and process simulation software (preferred)
A willingness to travel for project requirements including installation and start‑up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions
A bachelor of science in chemical or mechanical engineering, bioengineering, or a similar engineering degree with applicable life science industry, consulting, or project experience
About the Team Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. As a Process Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools.
Pay Range The approximate pay range for this position is $50 - $100 per hour. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.
Seniority level Associate
Employment type Contract
Job function Management and Manufacturing
#J-18808-Ljbffr