Precis Engineering + Architecture
Director or Process Engineering
Precis Engineering + Architecture, Cary, North Carolina, United States, 27518
Overview
Director – Process Engineering to lead and grow our Process Engineering team with a focus on pharmaceutical, biotechnology, and chemical manufacturing facility design. This leadership role will leverage deep expertise in Oral Solid Dosage (OSD) forms, aseptic processing, and advanced biomanufacturing technologies to drive the successful execution of complex facility design projects from conceptual development through detailed design. The ideal candidate will bring extensive hands-on experience in process systems design, clean utility generation, and advanced pharmaceutical equipment technologies. They will serve as both a technical leader and strategic visionary, responsible for mentoring talent and advancing Precis’s process engineering capabilities. Key Responsibilities
Lead, manage, and expand the Process Engineering group focused on OSD, Aseptic, Biotech and ATMP production facilities. Provide expert technical leadership in process system design, equipment selection, and clean utility generation/distribution systems. Oversee and provide quality control for conceptual and detailed design phases for highly complex pharmaceutical and biotechnology facilities. Guide the development of key design deliverables including MFDs, PFDs, P&IDs, and layout plans. Collaborate with cross-functional teams to ensure integration of automation, mechanical, architectural, and facility requirements. Champion innovation in continuous manufacturing, containment strategies, and advanced sterile fill/finish technologies. Direct preparation of technical documentation, equipment specifications, datasheets, white papers, and design philosophies. Ensure engineering quality control, technical accuracy, and adherence to cGMP, safety, and industry standards. Serve as a lead technical representative for client interactions, prospective project interviews, and project meetings. Advance Precis as thought leaders in the industry by authoring technical articles and presenting at industry conferences. Develop scope and commensurate design fees for process engineering discipline. Manage project responsibilities against pre-established budgets for each project. Actively participate in recruitment, mentoring, and professional development of the process engineering team. Technical Expertise
Oral Solid Dosage (OSD) forms and containment technology Advanced aseptic and barrier isolation technologies Design and integration of isolated filling lines (vial, syringe, BFS) Cleaning and sterilization systems (CIP, SIP, Sterilizers) Tablet compression, coating, encapsulation, and drying systems Clean utilities: RO/EDI systems, clean steam generators, multi-effect and vapor compression WFI stills Strong command of equipment and systems used in continuous manufacturing Biomanufacturing and sterile environments Qualifications
Bachelor’s or Master’s Degree in Chemical Engineering or related discipline. Professional engineering license preferred. 15+ years of progressive experience in process engineering, with a focus on pharmaceutical manufacturing facility design. Proven leadership experience managing multi-disciplinary engineering teams. Strong knowledge of cGMPs, FDA/EMA regulations, ISPE guidelines, and pharmaceutical best practices. Excellent communication skills with the ability to interface with clients, vendors, and internal stakeholders. Recognized industry expertise, participation in industry committees, conferences, or publications. Why Join Precis
Work on meaningful projects that directly impact public health and safety Be part of a collaborative, innovative team that values your ideas and expertise Grow your career through diverse project experiences and professional development opportunities Enjoy a flexible, supportive work environment and competitive compensation package Equal Opportunity Employer
Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.
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Director – Process Engineering to lead and grow our Process Engineering team with a focus on pharmaceutical, biotechnology, and chemical manufacturing facility design. This leadership role will leverage deep expertise in Oral Solid Dosage (OSD) forms, aseptic processing, and advanced biomanufacturing technologies to drive the successful execution of complex facility design projects from conceptual development through detailed design. The ideal candidate will bring extensive hands-on experience in process systems design, clean utility generation, and advanced pharmaceutical equipment technologies. They will serve as both a technical leader and strategic visionary, responsible for mentoring talent and advancing Precis’s process engineering capabilities. Key Responsibilities
Lead, manage, and expand the Process Engineering group focused on OSD, Aseptic, Biotech and ATMP production facilities. Provide expert technical leadership in process system design, equipment selection, and clean utility generation/distribution systems. Oversee and provide quality control for conceptual and detailed design phases for highly complex pharmaceutical and biotechnology facilities. Guide the development of key design deliverables including MFDs, PFDs, P&IDs, and layout plans. Collaborate with cross-functional teams to ensure integration of automation, mechanical, architectural, and facility requirements. Champion innovation in continuous manufacturing, containment strategies, and advanced sterile fill/finish technologies. Direct preparation of technical documentation, equipment specifications, datasheets, white papers, and design philosophies. Ensure engineering quality control, technical accuracy, and adherence to cGMP, safety, and industry standards. Serve as a lead technical representative for client interactions, prospective project interviews, and project meetings. Advance Precis as thought leaders in the industry by authoring technical articles and presenting at industry conferences. Develop scope and commensurate design fees for process engineering discipline. Manage project responsibilities against pre-established budgets for each project. Actively participate in recruitment, mentoring, and professional development of the process engineering team. Technical Expertise
Oral Solid Dosage (OSD) forms and containment technology Advanced aseptic and barrier isolation technologies Design and integration of isolated filling lines (vial, syringe, BFS) Cleaning and sterilization systems (CIP, SIP, Sterilizers) Tablet compression, coating, encapsulation, and drying systems Clean utilities: RO/EDI systems, clean steam generators, multi-effect and vapor compression WFI stills Strong command of equipment and systems used in continuous manufacturing Biomanufacturing and sterile environments Qualifications
Bachelor’s or Master’s Degree in Chemical Engineering or related discipline. Professional engineering license preferred. 15+ years of progressive experience in process engineering, with a focus on pharmaceutical manufacturing facility design. Proven leadership experience managing multi-disciplinary engineering teams. Strong knowledge of cGMPs, FDA/EMA regulations, ISPE guidelines, and pharmaceutical best practices. Excellent communication skills with the ability to interface with clients, vendors, and internal stakeholders. Recognized industry expertise, participation in industry committees, conferences, or publications. Why Join Precis
Work on meaningful projects that directly impact public health and safety Be part of a collaborative, innovative team that values your ideas and expertise Grow your career through diverse project experiences and professional development opportunities Enjoy a flexible, supportive work environment and competitive compensation package Equal Opportunity Employer
Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.
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