Sr Engineer

BioPharma Consulting JAD Group

About The Position

Independently provides leadership in process optimization, troubleshooting, and execution of engineering projects within manufacturing, pilot plant, or capital project environments. The Senior Engineer applies advanced engineering principles to design and implement complex system modifications, drive continuous improvement, and lead projects of significant scope and complexity across cross-functional teams.

Requirements

Strong knowledge of pharmaceutical/biotech manufacturing processes
Expertise in GMP/GLP regulations and highly regulated environments
Advanced understanding of validation processes and protocol execution
Ability to apply engineering principles to production systems and equipment
Strong analytical and problem-solving skills, including development of technical hypotheses
Proven ability to manage multiple projects and priorities simultaneously
Strong technical writing, reporting, and presentation skills
Effective communication and collaboration across diverse teams and stakeholders
Experience with specialized equipment and process systems
Ability to delegate, lead, and manage team performance
Working knowledge of financial analysis and project cost management
Doctorate degree OR Master’s degree + 2 years of Engineering experience OR Bachelor’s degree in Engineering + 4 years of Engineering experience

Nice To Haves

Strong experience with cGMP engineering practices in pharmaceutical/biotech environments
Experience with Quality Systems (e.g., Change Control, Non-Conformance, CAPA, Risk Assessments)
Experience with validation of new equipment and system installations
Familiarity with Maximo or similar asset management systems
Experience managing vendors, contractors, and purchase orders (POs)
Ability to work in fast-paced, multi-project environments with shifting priorities
Strong leadership, negotiation, and conflict resolution skills
Demonstrated ability to influence and drive cross-functional alignment

Responsibilities

Execute complex and novel engineering assignments, developing new or improved techniques and procedures
Develop and implement engineering policies and procedures impacting multiple departments
Supervise, coordinate, and review work of engineers, associates, and technicians
Apply advanced and cross-disciplinary engineering principles to diverse technical challenges
Serve as a subject matter expert (SME) in a specialized engineering area
Lead planning and execution of engineering projects and initiatives
Develop innovative technical solutions for complex engineering problems
Collaborate with Manufacturing, Quality, Validation, Facilities, Utilities, and Process Development teams on system and facility modifications
Partner with project managers to ensure projects are delivered on time, within scope, and within budget
Coordinate work with consultants, architects, and external engineering firms
Develop and manage project and departmental budgets
Support capital projects, including scope development, execution, and closure