Job Description

Job Description

Job Description

Title : Senior Engineer (3603237)

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents Only)

Position Details

• Number of Openings: 1
• Schedule: Onsite – Administrative Shift
• Contract Duration: 1 Year

Position Summary

Our client is seeking a Senior Engineer to support process optimization, troubleshooting, commissioning, qualification, and engineering project activities within a highly regulated pharmaceutical manufacturing environment.

The selected candidate will independently lead or support engineering initiatives involving process characterization, operational improvements, system modifications, validation activities, and capital projects. This role requires advanced engineering expertise, strong problem-solving capabilities, and the ability to manage complex technical projects while ensuring compliance with GMP and regulatory standards.

The ideal candidate will have experience supporting Assembly and Packaging operations, Commissioning & Qualification (C&Q) activities, validation execution, and cross-functional project coordination within pharmaceutical or biotech environments.

Preferred Qualifications

• Bachelor’s Degree in Engineering with 4+ years of Assembly and Packaging Process experience
• Experience supporting GMP-regulated pharmaceutical or biotech manufacturing operations
• Strong background in Commissioning & Qualification (C&Q) activities
• Experience with validation lifecycle activities including IQ, OQ, and PQ execution
• Knowledge of risk management methodologies such as ISPE Baseline and ASTM E2500
• Experience supporting Change Control, CAPA, and deviation management activities
• Strong technical writing, project coordination, and troubleshooting skills

Key Responsibilities

Commissioning & Qualification (C&Q) Strategy and Planning

• Develop and implement Commissioning & Qualification strategies aligned with project and regulatory requirements.
• Define system boundaries and identify direct and indirect impact systems.
• Lead risk assessments to determine qualification scope and system criticality.
• Develop C&Q plans, project schedules, and resource forecasting activities.

Commissioning Activities

• Execute and oversee commissioning activities, including FAT, SAT, and field commissioning.
• Ensure systems are installed and operating according to design specifications and user requirements.
• Coordinate startup activities with vendors, contractors, and internal stakeholders.
• Review and approve commissioning documentation, test results, and turnover packages.

Qualification Execution (IQ/OQ/PQ)

• Author, review, and approve qualification protocols and reports, including IQ, OQ, and PQ documentation.
• Ensure traceability between User Requirement Specifications (URS), testing activities, and final validation documentation.
• Support or oversee protocol execution activities while ensuring proper documentation practices and compliance standards.

Documentation & Compliance

• Ensure all C&Q and validation documentation complies with GMP, FDA, EMA, and internal quality standards.
• Maintain documentation lifecycle activities within electronic quality systems.
• Support ALCOA+ data integrity principles throughout qualification and validation activities.
• Prepare validation summary reports and support audit readiness initiatives.

Risk Management & Change Control

• Lead and document risk assessments associated with system qualification and process modifications.
• Evaluate and manage Change Controls impacting validated systems and manufacturing operations.
• Assess deviations, determine operational impact, and implement corrective and preventive actions (CAPAs).

Cross-Functional Coordination

• Collaborate with Engineering, Validation, Manufacturing, Quality Assurance, Supply Chain, and Process Development teams.
• Interface with system owners, technical SMEs, contractors, and project stakeholders.
• Provide technical guidance and mentorship to junior engineers and project team members.
• Support project meetings, technical presentations, status reporting, and stakeholder communications.

Process Characterization

• Develop characterization protocols and testing strategies.
• Execute characterization studies and data collection activities.
• Analyze data and prepare characterization reports supporting process optimization and validation efforts.

Essential Functions

General Engineering Responsibilities

• Complete complex engineering assignments requiring development of new or improved engineering techniques and procedures.
• Develop engineering procedures and policies impacting multiple operational areas.
• Coordinate and review work performed by engineers, associates, technicians, consultants, and contractors.
• Apply advanced engineering principles to solve technical and operational challenges.
• Support multiple engineering projects simultaneously while meeting schedule, quality, and budget objectives.
• Serve as a technical resource and subject matter expert within assigned engineering disciplines.

Design Engineering Support

• Develop technical solutions for complex engineering and operational problems.
• Partner with Manufacturing, Utilities, Facilities, Validation, Process Development, and Quality teams to support system and facility modifications.
• Collaborate with project managers to ensure engineering deliverables are completed within established timelines and project constraints.
• Coordinate external engineering firms, consultants, and contractors during project execution activities.
• Assist in development and management of project budgets and engineering resource plans.

Education Requirements

Candidates must meet one of the following education and experience combinations:

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

Required Skills & Competencies

Technical Knowledge

• Working knowledge of pharmaceutical and biotech manufacturing processes
• Strong understanding of validation lifecycle activities and qualification requirements
• Experience within highly regulated GMP environments
• Knowledge of FDA, EMA, GLP, and GMP regulations
• Familiarity with Assembly and Packaging systems and equipment
• Understanding of Change Control, CAPA, and deviation management processes

Engineering & Validation Skills

• Validation protocol writing and execution
• Equipment qualification and startup support
• Technical troubleshooting and analytical problem-solving
• Process characterization and optimization
• Risk assessment and mitigation
• Specialized equipment and process expertise

Communication & Project Management

• Strong technical writing and presentation skills
• Effective verbal and cross-functional communication abilities
• Ability to manage multiple projects and competing priorities simultaneously
• Collaboration and stakeholder management skills
• Basic project management and schedule development experience
• Ability to independently identify and coordinate internal or external resources as needed

Computer & Analytical Skills

• Computer literacy and engineering systems proficiency
• Data analysis and technical reporting capabilities
• Familiarity with financial analysis tools
• Strong organizational and follow-up skills

Leadership & Collaboration

• Ability to lead technical discussions and facilitate project meetings
• Experience mentoring or coordinating junior staff and technical teams
• Strong collaboration skills across multiple organizational functions
• Ability to provide technical solutions for complex engineering challenges

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