Lead Process Engineers & Managers - Project Farma

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Lead Process Engineers & Managers - Project Farma

Location(s)

Raleigh, NC

Job Description

Project Farma is growing our Manufacturing & Tech Ops - Process Engineering practice, and will consider candidates' ranging from 5-15 years' relevant experience.

The successful candidate will reside within 50 miles of Raleigh, NC and be willing to travel domestically to meet client project requests.

Project Farma’s purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

All team members are expected to embody Project Farma’s values by being curious , personable , and unselfish , while maintaining a strong commitment to a Patient Focused and People First mindset .

Process Design

Provide technical leadership and oversight for process design activities associated with one or more of the following practice areas:

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.

The annual compensation range for this full-time position is $90,000 - $175,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Responsibilities

Serve as the company’s Process Engineering Owner’s Representative throughout facility planning, conceptual design, basic design, detailed design, construction, commissioning, and qualification, as applicable.; Provide day-to-day technical oversight of the A&E firm’s process engineering activities and deliverables.; Establish expectations for process engineering scope, design criteria, deliverables, and technical standards.; Review, challenge, and approve A&E process engineering deliverables on behalf of the Owner.; Ensure A&E designs appropriately reflect the company’s User Requirements, process requirements, operational philosophy, and applicable engineering standards.; Identify design gaps, inconsistencies, risks, and opportunities for optimization before they impact project cost, schedule, quality, or operability.; Coordinate process engineering activities with architectural, mechanical, electrical, automation, structural, civil, environmental, and other engineering disciplines.; Participate in design reviews, HAZOPs, risk assessments, constructability reviews, operability reviews, and value-engineering exercises.; Ensure that design decisions are appropriately documented and technically justified.; Monitor A&E performance against project scope, schedule, budget, and quality expectations.; Sterile formulation and compounding; Aseptic processing and filling; Cleanroom and controlled-environment requirements; Material and personnel flows; Equipment and process skids; CIP/SIP and sterilization processes; Clean utilities and process gases; Barrier technologies including RABS and isolators; Single-use technologies; Process equipment and facility integration; Dispensing and material handling; Milling, blending, granulation, drying, and compression; Coating and encapsulation; Tablet/capsule processing; Containment and dust-control strategies; Process equipment and material-transfer systems; Packaging interfaces and manufacturing flows; Bioconjugation and ADC process operations; Highly potent compound handling and containment; Antibody and linker-related process considerations; Lipid nanoparticle formulation and processing; Nanoparticle drug product operations; Solvent handling and recovery considerations; Containment, segregation, and personnel/material flow; Single-use process technologies; Primary and secondary packaging operations; Drug-device combination products; Automated packaging equipment; Device assembly and integration; Serialization and aggregation systems

Requirements

Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience.; Approximately 5–10 years of relevant pharmaceutical, biotechnology, or life-sciences engineering experience.; Demonstrated experience with pharmaceutical or biotechnology facility design, process engineering, or capital project execution.; Experience working with or managing Architecture & Engineering firms and/or engineering contractors.; Demonstrated ability to function effectively as an Owner’s Representative.; Strong understanding of GMP manufacturing environments and pharmaceutical engineering practices.; Ability to independently review and challenge process engineering deliverables.; Experience developing or reviewing PFDs, P&IDs, equipment specifications, layouts, process descriptions, and utility requirements.; Strong understanding of the relationship between process requirements and facility design.; Excellent written, verbal, organizational, and interpersonal communication skills.; Ability to manage multiple priorities in a global, matrixed organization.; Willingness to travel as required for client project assignments.

Nice to have

Experience in one or more of the following:; Sterile drug product manufacturing; Aseptic processing; Oral solid dosage manufacturing; ADC manufacturing; High-potency API or drug-product containment; Lipid nanoparticle manufacturing; Drug-device combination products; Automated packaging and inspection systems; Experience with RABS, isolators, single-use systems, CIP/SIP, sterilization, or clean utilities.; Experience with process equipment selection and vendor management.; Experience participating in HAZOP, FMEA, design qualification, commissioning, and qualification activities.; Familiarity with ISPE Baseline Guides and Good Practice Guides.; Familiarity with FDA and EU GMP expectations for pharmaceutical manufacturing facilities.; Experience working on international projects and with globally distributed engineering teams.