Title: Sr. Engineer (3458775)

Location: East of Puerto Rico (Open to Puerto Rico Residents who are U.S. Citizens)

Work Schedule: 100% Onsite, Administrative Shift

Positions: 1

Duration: Approximately 10 months

Summary

Our client is seeking a Sr. Engineer to independently provide and/or direct the characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital project environments. The role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, process improvements, and capital projects. The Sr. Engineer develops, organizes, analyzes, and presents interpretations of results for operational issues or engineering projects of significant scope and complexity.

Preferred Qualifications

Candidates should possess experience in biotechnology or pharmaceutical manufacturing, particularly in downstream processes. Responsibilities include managing SOPs, eBRs, and change controls, as well as initiating, revising, and approving controlled documents in the document management system. This may include serving as a document author, owner, reviewer, or data verifier to ensure all controlled documents accurately reflect current operations and compliance standards.

Key responsibilities include:

• Implement new product introductions and major projects within Drug Substance (DS) operations. Collaborate with capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including:
• Procedures and batch records
• Automation and materials
• New equipment introduction/modifications
• Cleaning, changeover, and process validation
• Training and floor readiness
• Analyze floor operations data and observations to identify root causes of deviations or inefficiencies. Develop and implement data-driven solutions to improve processes and enhance operational performance.
• Ensure timely investigation and resolution of deviations within established goals, performing deviation assessments, supporting root cause analysis (RCA), human performance evaluations, and CAPA development. Monitor CAPA effectiveness to prevent recurrence.
• Assist in the development and execution of process validation protocols and reports. Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
• Support the establishment of process monitoring parameters and control limits, ensuring timely execution of process performance or validation reports and deviation assessments.
• Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
• Support monitoring initiatives by configuring requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire). Ensure configurations align with process design, GMP requirements, and client standards. Collaborate with process owners, process development, and automation teams to implement new or modified processes.
• Utilize Application Life Cycle Management (ALM) during validations and navigate SAP for master data, process orders, production versions, inventory, and bill of materials (BOMs). Troubleshoot SAP-MES PAS/X connectivity issues and maintain alignment between SAP and MES configurations.
• Assess, prioritize, justify, and support implementation of process or equipment modifications, providing project management support. Participate in special projects or initiatives to enhance manufacturing operations.

Functions

General Responsibilities

• Complete complex or novel assignments requiring the development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures affecting multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and technicians on an ongoing and project basis.
• Apply advanced engineering techniques and principles across related fields.
• Serve as a peer-recognized engineering technology specialist in at least one area, determining methodologies and applying mature engineering knowledge to planning and conducting projects.

Design Engineering Responsibilities

• Develop technical solutions to complex problems requiring creativity and ingenuity.
• Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation teams to develop requirements and recommendations for large or complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
• Coordinate with consultants, architects, and engineering firms to develop standard design documents.
• Develop departmental or project budgets encompassing multiple disciplines.

Education

• Doctorate OR
• Master’s degree + 2 years of Engineering experience OR
• Bachelor’s degree in Engineering + 4 years of Engineering experience

Competencies / Skills

• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes and highly regulated documentation
• Ability to operate specialized laboratory equipment and computers
• Ability to interpret and apply GLPs and GMPs
• Ability to apply engineering principles to production and solve technical problems
• Problem-solving, technical report writing, and verbal communication skills
• Knowledge of validation protocol execution requirements

Demonstrated skills include:

• Technical presentations and validation protocol writing
• Managing change, analytical problem-solving, and computer literacy
• Specialized equipment/process expertise and in-depth validation knowledge
• Collaboration, project management, and schedule development
• Leadership, negotiation, persuasion, conflict resolution, and teambuilding
• Management of contractors, vendors, and multiple projects simultaneously

We encourage qualified candidates who are ready to contribute to impactful engineering projects to apply inside the job description link with an updated resume.