The GMP Manufacturing Operations, Process Engineer will be responsible for assisting manufacturing operations staff and partnering with planning and execution of all technical aspects of product and/or process technology transfer. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete process to manufacturing. Individuals in this role work closely with Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards. Due to the production schedule, the work schedule for this position will vary from month to month but is generally during the first shift (0800-1630 hours).
Key Areas of Focus
- Provide primary site technical support for the entire Tech Transfer process from initial evaluation to PPQ, including change control ownership, in compliance with site procedures.
- Define and own technical requirements for new equipment design specifications (URS).
- Develop and own site Control Strategy Documents for processes transferred.
- Work with Project Managers to ensure proper planning of MSAT activities to meet timelines.
- Communicate priorities and progress to team on a continuing basis.
- Develop and execute development studies in support of new equipment, products, and processes.
- Make detailed observations, analyze data, and interpret results.
- Ensure proper documentation of activities, actions, and/or results.
- Create documents required for new process execution in Operations, including SOPs, Batch Records, Specifications, Initial and ongoing Validation requirements, etc.
- Ensure that Operations has all tools needed to execute new processes in an efficient and compliant manner.
- At the point of process transfer to Operations (PPQ), assure validated state of the process and clear definition and documentation of controls required to maintain validated state.
- Provide leadership, development, and mentoring of Operations colleagues during Tech Transfer and qualification activities.
- Provide support for regulatory inspections as technical process owner.
- Coordinate the activities of external resources as required.
- Effectively present technical data in an understandable fashion to support decision making.
- Maintain a high level of expertise through review of relevant scientific literature and regulatory guidelines.
- Perform work requirements in a responsible manner in accordance with SOPs, CGMPs and safety procedures in accordance with OSHA requirements and company Environmental Health and Safety (EHS) guidelines.
- Contribute to the development of group and site culture by exercising creativity in dealing with new problems encountered within an evolving organization.
- Take an active role in finding solutions and improvements for the facility.
- Work with minimal supervision under the direction of GMP Manufacturing Operations Management and MSAT Tech transfer teams.
- Maintain classified area gowning certifications to support assigned tasks, as required.
- Other duties as assigned to support GMP Operations.
Desired skills and background
- Proven ability to work effectively in a team environment.
- Ability to generate and interpret technical documents.
- Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
- Ability to lift and handle equipment and materials associated with engineering study execution.
- Willingness and ability to maintain aseptic gowning certification as established by company procedures.
- Preferred Qualifications
- Bachelor’s degree or 2-year technical degree with equivalent experience
- At least 5 years of experience in process development, tech transfer, or engineering, with at least 3 years in biopharmaceuticals or a similar regulated industry.
- Prior Tech Transfer experience in bioprocessing or related industry, including formulation, sterile filtration, aseptic filling, automated visual inspection, and/or packaging and labeling.
- Previous experience with automated equipment, including recipe creation and process control logic.
- Experience with Continuous Improvement systems.
How to Apply
If you feel that you are a great match for this position and want to make a difference in the exciting field of next-generation therapeutics, then reach out to us at [email protected] and be sure to include your resume and cover letter. We look forward to hearing from you!
Vernal is an equal opportunity employer. We recognize the value of diverse, multifaceted approaches towards innovation and aim to incorporate diverse perspectives and experiences. We strive to build a safe, welcoming, and inclusive work culture.
At Vernal, you will offer knowledge-based solutions to help us address the growing demand for mRNA, lipid nanoparticle (LNP) mRNA, drug screening, and ultimately clinical supply of mRNA. Together, we will create the most integrated solution for mRNA vaccines and therapeutic R&D. Vernal will become the only one-stop-shop for our clients’ and partners’ mRNA needs, from concept all the way to clinical trials. The mRNA research associate or scientist will develop methods to synthesize, purify, and scale up mRNA. As a startup, we are seeking adaptable, creative thinkers who can independently foresee gaps and opportunities and who take the initiative to solve problems with a sense of urgency. We expect the work to be rewarding, fast-paced, and to offer ample opportunities to plan and create new solutions to help grow our business. Vernal will pay a competitive salary with generous benefits including health, dental, and vision insurance. Although hiring level will depend on experience, we expect to grow with our employees and are interested in a variety of backgrounds.
Vernal Biosciences is located in Colchester, Vermont, adjacent to Burlington which is home of the University of Vermont and the UVM Medical Center. Check out https://www.helloburlingtonvt.com/ for more information. The Burlington area, set on the shores of Lake Champlain, features the best of two worlds:
- Multicultural hub with great schools, restaurants, breweries, shopping, arts, and an affordable cost of living
- Gateway to the Green Mountains including world class hiking, camping, bicycling, and alpine and Nordic skiing