ZL01-072126 Process Development Sr Scientist

Pinnaql; Juncos (PR); On-site; USD 120,000 - 190,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a Process Development Sr Scientist to independently design and advance experiments that support sterile drug product manufacturing, process characterization, and PPQ activities.

You will lead cross-functional work with Quality, Manufacturing, Regulatory and Tech Services, develop robust protocols, interpret data, and contribute to technology transfer and commercial readiness.

Qualifications

• Advanced degree required with relevant experience in sterile drug product development.
• Experience authoring validation protocols and technical reports.
• Strong GMP knowledge and data-driven process optimization.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Independently design and advance experiments for process development.
• Conduct data analysis to interpret results and influence decisions.
• Lead cross-functional collaborations with Manufacturing, Quality, and Regulatory.
• Develop and execute PPQ studies and technology transfer plans.
• Prepare technical reports and participate in change controls.

Skills

Sterile drug manufacturing

Aseptic filling operations

Process validation PPQ

Technology transfer

Validation protocols

Technical reports

Statistical analysis JMP/Minitab

Data-driven optimization

Cross-functional teamwork

Technical writing

Project management

Single-use technologies

Education

Doctorate (PhD, PharmD, or MD) with postdoc experience

Master's degree with 3+ years of relevant experience

Bachelor's degree with 5+ years of relevant experience

Degree in Mechanical/Chemical/Biomedical/Bioprocess Engineering or related science

Tools

JMP

Minitab

Job description

ZL01-072126 Process Development Sr Scientist

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

1. Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies
2. Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations
3. Expands knowledge-seeking beyond core area of expertise
4. Identifies relevant external competitive knowledge
5. Independently prepares new and novel protocols/experimental design
6. Key contributor to an independent research/project team
7. Initiates productive collaborations outside of the department or company
8. Introduces new or advanced technologies and/or concepts
9. May contribute to scientific journal articles or complex technical documents as lead author
10. Leads department-wide support efforts such as safety, recruiting and committees
11. Develops supervisory and mentoring skills
12. Makes proactive decisions that contribute to the achievement of milestones
13. 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.