ZL01-072126 Process Development Sr Scientist

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 120,000 - 170,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Process Development Sr Scientist to independently design and advance scientific experiments in a fast-paced pharma/biotech setting.

The role emphasizes aseptic filling, process characterization, and PPQ validation, with cross-functional collaboration across Manufacturing, Quality, and Regulatory teams to drive commercial readiness and continuous improvement.

Qualifications

• PhD/PharmD/MD with relevant postdoc experience, or MS with 3+ years relevant scientific experience, or BS with 5+ years relevant experience.
• Degree in engineering/bioprocess/pharma sciences is highly preferred.
• Experience supporting sterile drug product manufacturing in pharma/biotech.
• Experience authoring and executing validation protocols, reports, investigations, and change controls.

Responsibilities

• Independently conceive, design, implement and advance scientific experiments to meet project goals.
• Provide advanced data analysis, interpret results, and recommend data-driven actions.
• Lead cross-functional collaborations across Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Plan detailed procedures with timelines, milestones, and required resources.

Skills

Sterile drug manufacturing

Aseptic filling operations

Process validation (PPQ)

Technology transfer

Statistical analysis

Cross-functional collaboration

Technical writing

Project management

Education

PhD/PharmD/MD (+ relevant postdoc)

MS with 3+ years relevant experience

BS with 5+ years relevant experience

Preferred: Mechanical/Chemical/Biomedical/Bioprocess/Pharmaceutical sciences or related

Tools

JMP

Minitab

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

• Process Development Sr Scientist

Education

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or
• Master's degree with 3+ years of relevant scientific experience; or
• Bachelor's degree with 5+ years of relevant scientific experience.
• A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.

Attributes

• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast‑paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single‑use technologies, filling equipment, and sterile manufacturing operations is highly desirable.

Summary

To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or leads these activities. Provides input to new processes to generate robust and reliable data. Functions as a lead scientific / technical resource or as a project leader.

Functions

• Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies
• Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations
• Expands knowledge‑seeking beyond core area of expertise
• Identifies relevant external competitive knowledge
• Independently prepares new and novel protocols/experimental design
• Key contributor to an independent research/project team
• Initiates productive collaborations outside of the department or company
• Introduces new or advanced technologies and/or concepts
• May contribute to scientific journal articles or complex technical documents as lead author
• Leads department‑wide support efforts such as safety, recruiting and committees
• Develops supervisory and mentoring skills
• Makes proactive decisions that contribute to the achievement of milestones
• Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose‑driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.