Technical Design and GMP Lead (Pharmaceutical - Construction)

Job description

At Cumming Group, you will work on some of the world's most exciting projects in a dynamic environment where your success is measured by the impact you make. We are one of the fastest-growing project and cost management consultancies in the United States, as reflected in our top 10 rankings in ENR. With over 60 offices globally, an extremely diverse project portfolio, and double-digit year-over-year revenue growth, the opportunities to make your mark are limitless! Essential Duties & Responsibilities: Provide owner-side technical oversight of pharmaceutical facility design and engineering. Review concept, basic design, detailed design, vendor, and construction packages for technical and cGMP compliance. Confirm user, manufacturing, operational, validation, and regulatory requirements are incorporated into design. Review process, mechanical, piping, HVAC, cleanroom, electrical, automation, utility, laboratory, warehouse, and support-building designs. Review process and clean utility systems, including purified water, water for injection where applicable, clean steam, process gases, compressed air, HVAC, and waste systems. Evaluate personnel, material, waste, equipment, and product flows. Review room classifications, pressure cascades, zoning, containment, environmental conditions, and hygienic design. Review equipment layouts, P&IDs, utility requirements, specifications, and control philosophies. Coordinate technical interfaces across manufacturing buildings, central utilities, laboratories, tank farms, warehouses, and infrastructure. Identify design gaps, technical conflicts, constructability issues, and GMP risks. Support HAZOPs, process hazard analyses, design-risk assessments, and technical change control. Confirm designs support commissioning, qualification, cleaning, maintenance, operation, and future expansion. Knowledge & Skills Required: cGMP pharmaceutical facility design and engineering. API, peptide, biologics, monoclonal antibody, bioconjugate, or comparable manufacturing processes. Process systems, clean utilities, HVAC, cleanrooms, laboratories, automation, and material handling. Contamination control, segregation, containment, hygienic design, and cleanability. Process flow diagrams, P&IDs, equipment layouts, utility diagrams, control narratives, and engineering specifications. FDA and EMA expectations, ISPE guidance, ASME BPE, NFPA, and applicable engineering standards. CQV, Quality by Design, data integrity, process safety, and operational readiness. Preferred Education and Experience: Bachelor’s degree in Chemical, Mechanical, Process, Biochemical, or Pharmaceutical Engineering. 12+ years of pharmaceutical engineering or capital-project experience. 5+ years in a Technical Lead, Engineering Lead, Design Manager, or GMP Lead role. Greenfield cGMP design, construction, CQV, and startup experience. Professional Engineer registration preferred. #LI-JB1 Cumming Group is committed to providing Equal Employment Opportunity in its personnel policies and practices. It is Cumming Group’s policy to recruit, hire, train and promote Team Members and applicants for employment without regard to race, color, creed, religion, age, sex, marital status, registered domestic partner status, genetic information, sexual preference, sexual orientation, gender (including gender expression and gender identity), pregnancy (including childbirth or related medical conditions, including breastfeeding), military service, national origin, ancestry, citizenship, physical disability, mental disability, veteran status or any other protected classification under federal, state, or local law. All such decisions are based on (1) individual merit, qualifications, and competence as they relate to the particular position, and (2) promotion of the principle of equal employment opportunity. All other terms and conditions of employment, such as compensation, benefits, transfers, layoff, return from layoff, training, education, and social and recreational programs, are administered without regard to the characteristics described above. To this end, Cumming Group complies with all provisions of Title VII of the Civil Rights Act of 1964 as amended, all of the rules, regulations and relevant orders of the Secretary of Labor, and all similar state and local laws. The salary range for this full-time role is $115,700.00-$161,966.69 per year. Ranges are determined based on the position, geography, client and industry experience and level, and represent a good faith effort to provide a fair and equitable salary. This range reflects base salary only, and not the total compensation package. Cumming Group reserves the right to pay more or less than the posted range, depending on a candidate’s experience, skills, and qualifications, including client requirements. In addition to base salary, Cumming Group offers a comprehensive benefits package including: Medical Dental Insurance Vision Insurance 401(k) 401(k) Matching Paid Time Off Paid Holidays Short and long-term disability Employee Assistance Program