Senior Process Engineer
Location: Bedford, MA
Summary of Primary Responsibilities:
The Senior Process Engineer will lead complex technical tasks and engineering process improvement projects, develop new processes and provide engineering support for existing processes. This individual will ensure that the highest standards of safety and compliance are maintained in the workplace and operate under the regulatory requirements dictated by the industry. The successful candidate will work effectively in highly cross-functional project teams in a dynamic and motivated environment as well as demonstrate that they are able to work independently to accomplish project objectives.
- Leads the process design efforts for new manufacturing concepts. Coordinates external collaborations with vendors and outside resources to design and test concepts.
- In collaboration with Commercial Operations, recommends, develops and implements process improvements to cost effectively produce products which meet critical product attributes.
- Generates conceptual, preliminary and detailed engineering designs, drawings, test plans and specifications
- Manages self for timely completion of tasks per plan with minimal direct supervision.
- Serves as technical lead and works collaboratively as part of multi-disciplinary project teams
- Leads project teams in the development, optimization, transfer and validation of cost effective processes from R&D to pilot scale to commercial scale.
- Conducts design verification activities at laboratory, pilot, and commercial scale according to design control, change control and risk assessment procedures.
- Maintains detailed documentation throughout all phases of development to commercialization. Prepares comprehensive development and validation protocols and reports detailing procedures, test methods, results and conclusions of all work.
- Through experiments, literature searches, and internal and external interactions, identifies new technologies aimed at improving manufacturing efficiencies, and product quality.
- Performs experiments to screen critical process control factors. Uses experimental design techniques to develop robust processes.
- Performs other related duties and projects as required
Works on problems of diverse and highly technical scope requiring critical thinking and interaction with internal and external technical professionals. Capable of leading complex, large capital projects. Designs and develops new manufacturing processes and technologies as well as improves current manufacturing processes to drive business results. Exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.
No direct reports, however, must be able to participate in multi-disciplined project teams manage vendors, contractors and consultants as required.
Experience, Knowledge, and Skills Required:
- BS Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Industrial Engineering or related fields. Master of Science in Engineering/MBA is a plus
- Minimum of 8 years of progressive experience in the area of process engineering for medical device, biotechnological or pharmaceutical industries.
- Knowledge of manufacturing equipment (benchtop / pilot / commercial), process and systems used in cGXP industries, including aseptic processing.
- Knowledge of equipment fabrication techniques, cost estimation, and ability to create and review process flow diagrams.
- Experience in design of sanitary process systems including preparation of process flow diagrams, material balances and P&IDs
- Strong communication skills – verbal, written, listening and interpersonal with the ability to transfer knowledge to others
- Working knowledge of statistical techniques and tools to control a process, monitor process behavior, discover issues in internal systems, and find solutions for production issues.
- Experience with Microsoft Office Suite
- Strong leadership, relationship management, and organizational planning and project management skills
Desired Experience, Knowledge, and Skills:
- Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results
- Knowledge of post-implementation continuous process improvement efforts and methodology
- Knowledge of regulatory compliance requirements
- Familiarity with Lean Manufacturing/Six Sigma
- Working knowledge of Design of Experiments, statistical data analysis and modeling
- Understanding of Quality Systems requirements.
- Familiarity with AutoCAD, Solid works, and Allen Bradley PLCs
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.