Senior Process Engineer

BioPharma Consulting JAD Group

About The Position

The Senior Engineer independently leads and directs process optimization, troubleshooting, system/facility modifications, and capital project activities within operations, manufacturing, pilot plant, and engineering environments. This role applies advanced engineering principles to design and implement major system changes, experiments, and process improvements.

Requirements

Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes and protocol execution
Experience with documentation in highly regulated environments
Ability to operate specialized laboratory and engineering equipment
Ability to interpret and apply GLP, GMP, GDP
Ability to apply engineering science to production systems
Ability to develop solutions to technical problems of limited to moderate scope
Strong problem‑solving and applied engineering skills
Technical report writing and verbal communication skills
Understanding of validation requirements for new equipment installations
Ability to manage multiple projects simultaneously
Ability to determine when internal or external resources are required
Collaboration, facilitation, schedule development, and project management skills
Ability to delegate and manage project work of others
Working knowledge of financial analysis tools
Leadership, conflict resolution, negotiation, and vendor/contractor management

Nice To Haves

In‑depth experience with bio‑processing unit operations
Knowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why’s, Kepner‑Tregoe)
Familiarity with Lean Manufacturing practices
Strong communication and collaboration skills across manufacturing, process development, and quality
Proficiency in GDP within regulated environments
Experience with systems such as TrackWise, Spotfire, CDOCS, and process monitoring platforms
Strong technical writing and presentation skills
Excellent written and verbal communication skills in English and Spanish

Responsibilities

Execute complex or novel engineering assignments requiring development of new or improved techniques and procedures.
Develop engineering policies and procedures impacting multiple organizational units.
Apply advanced engineering techniques and adapt specialized methods to diverse assignments.
Utilize engineering knowledge beyond core discipline to support cross‑functional initiatives.
Serve as a peer‑recognized SME responsible for determining methodologies in at least one engineering technology area.
Apply mature engineering judgment in planning and conducting projects.
Develop technical solutions to complex problems requiring creativity, innovation, and engineering expertise.
Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for major system or facility modifications.
Partner with Project Managers to deliver engineering projects within schedule, budget, and quality expectations.
Coordinate external consultants, architects, and engineering firms in developing standard design documentation.
Develop departmental or multi‑disciplinary project budgets and manage cost controls for assigned areas.
Own change controls for manufacturing process changes.
Support major/trend deviation investigations, including root cause analysis, CAPA determination, authoring investigation reports, and presenting during regulatory inspections.
Support risk assessments and microbial evaluation activities.
Design, coordinate, and support execution of functional tests, water tests, and challenge runs for major changes or campaign readiness; generate technical protocols as needed.
Provide guidance during MBR (Master Batch Record) creation and revisions.
Perform assessments supporting process, automation, or equipment modifications and special projects.
Complete assessments for new or modified BOMs (Bill of Materials).