Senior Process Engineer - BioPharma Consulting JAD Group : Job Details

We are seeking an experienced and innovative Senior Process Engineer to independently lead and contribute to complex engineering initiatives, including process optimization, troubleshooting, and major system modifications within a manufacturing or capital projects environment.

Key Responsibilities:

• Lead complex or novel engineering assignments requiring new and/or improved techniques and procedures.
• Develop policies and SOPs that impact multiple departments or units.
• Supervise and coordinate the work of engineers, associates, or technicians on both project and day-to-day basis.
• Apply expertise across various engineering disciplines and serve as a subject matter expert in at least one specialized area.
• Provide technical leadership in planning, executing, and reporting on large-scale engineering or capital projects.
• Generate innovative technical solutions for challenging problems using scientific and engineering principles.
• Collaborate with R&D, Manufacturing, Facilities, QA, and Validation to develop and implement complex system or process changes.
• Participate in and/or manage design development efforts with consultants, architects, or engineering partners.
• Develop and manage project and departmental budgets, timelines, and scopes.
• Support or lead process validation efforts including protocol development, test runs, data collection, and technical report authoring.
• Apply in-depth knowledge of cGMP, GLP, and validation protocol execution.
• Ensure documentation complies with regulatory standards and internal quality systems.

Competencies & Skills:

• Familiarity with pharmaceutical manufacturing processes (e.g., filling, formulation).
• Equipment-specific technical knowledge.
• Skilled in protocol/test run writing and technical report authoring.
• Ability to manage multiple projects simultaneously.
• Schedule and budget development.
• Vendor and contractor coordination.
• Strong collaboration and facilitation skills.
• Conflict resolution and cross-functional communication.
• Ability to lead and mentor junior team members.

• Education:
• PhD in Engineering; OR
• Master's in Engineering + 2 years' experience; OR
• Bachelor's in Engineering + 4 years' experience.
• Experience:
• Proven experience in a biotech/pharmaceutical environment.
• Strong understanding of validation, equipment qualification, and manufacturing systems.
• Hands-on knowledge in process optimization and troubleshooting.

Preferred Qualifications:

• Expertise in process validation, protocol development, and execution.
• Demonstrated success in managing filling line operations or technical transfers.
• Working knowledge of Oracle, PeopleSoft, or similar ERP systems.
• Proficient in Microsoft Office, especially Excel and PowerPoint.
• Strong written and verbal communication skills, including technical documentation.

• Administrative Shift
• 1-year contract