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 ethics standards for the following position:
- Project Manager – Downstream Biologics
Description:
Leads capital projects within downstream biologics manufacturing, supporting capacity expansion and facility enhancements within existing operations. Manages projects through the full project lifecycle from concept through engineering, construction, and CQV, ensuring alignment with business and site objectives.
Responsibilities:
- Lead capital projects from initiation through design, construction, and CQV completion.
- Manage projects related to downstream biologics processes, including fill/finish, cell culture, reactors, and related systems.
- Drive capacity expansion initiatives within existing manufacturing facilities.
- Coordinate cross-functional teams including Engineering, Site Operations, and CQV stakeholders.
- Present project updates, project status, and key decisions to Global Engineering leadership and site executives.
- Ensure adherence to scope, schedule, cost, and quality objectives.
- Manage project execution to support business goals and site operational requirements.
- Facilitate communication and collaboration across project teams and stakeholders.
- Support project planning, risk management, and decision-making throughout the project lifecycle.
Qualifications:
- Experience leading capital projects within pharmaceutical, biotechnology, or biologics manufacturing environments.
- Strong knowledge of downstream biologics manufacturing processes, including fill/finish, cell culture, reactors, and associated process systems.
- Experience managing projects through engineering, construction, commissioning, qualification, and validation (CQV) phases.
- Experience supporting manufacturing capacity expansion projects within existing operating facilities.
- Strong project management skills with demonstrated ability to manage scope, schedule, cost, and quality objectives.
- Experience leading cross-functional teams and coordinating multiple stakeholders.
- Strong leadership, communication, and presentation skills.
- Ability to present project updates and strategic recommendations to senior leadership and executive stakeholders.
- Strong organizational, analytical, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced project environment.
- Available to work extended hours, possibility of weekends and holidays.
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.
Skills Required
- Experience leading capital projects within pharmaceutical, biotechnology, or biologics manufacturing environments
- Strong knowledge of downstream biologics manufacturing processes (fill/finish, cell culture, reactors, associated process systems)
- Experience managing projects through engineering, construction, commissioning, qualification, and validation (CQV)
- Experience supporting manufacturing capacity expansion projects within existing operating facilities
- Strong project management skills with demonstrated ability to manage scope, schedule, cost, and quality objectives
- Experience leading cross-functional teams and coordinating multiple stakeholders
- Strong leadership, communication, and presentation skills, including presenting to senior leadership and executives
- Strong organizational, analytical, and problem-solving skills
- Ability to manage multiple priorities in a fast-paced project environment
- Availability to work extended hours, including possible weekends and holidays
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
