Senior Engineer (3608845)
ProQualityNetwork
Job Description
Job Description
Senior Engineer (3608845)
Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)
Work Schedule: Onsite – Administrative Shift
Contract Duration: 8 Months
Position Summary
Our client is seeking a highly motivated Senior Engineer to independently lead and support process optimization initiatives, equipment troubleshooting, validation activities, and engineering projects within manufacturing, operations, pilot plant, and capital project environments.
The selected candidate will apply advanced engineering principles to the design, implementation, and execution of complex system modifications, process improvements, validation strategies, and capital projects. This role requires the ability to analyze technical challenges, interpret results, develop innovative solutions, and provide technical leadership across multidisciplinary teams.
Preferred areas of Expertise:
- Bachelor's Degree in Engineering and a minimum of four (4) years of engineering experience.
- Experience in:
- Commissioning & Qualification (C&Q)
- Equipment Validation
- Packaging Equipment
- Process Validation
- Experience within pharmaceutical, biotechnology, or highly regulated manufacturing environments is preferred.
Key Responsibilities
General Engineering Responsibilities
- Complete complex and innovative engineering assignments requiring the development of new or enhanced engineering techniques and procedures.
- Develop engineering policies, standards, and procedures that impact multiple organizational units.
- Provide technical leadership and supervision to engineers, associates, and technicians on both project-based and ongoing operational activities.
- Apply advanced engineering principles and methodologies within areas of expertise.
- Utilize multidisciplinary engineering knowledge to solve a broad range of technical challenges.
- Serve as a recognized technical expert in at least one engineering discipline and determine methodologies and best practices within that area.
- Lead engineering projects from planning through execution while ensuring compliance with quality and regulatory requirements.
- Support continuous improvement initiatives and operational excellence programs.
- Perform additional duties as assigned.
Design Engineering Responsibilities
- Develop technical solutions to complex engineering problems requiring creativity, innovation, and sound technical judgment.
- Collaborate with Research & Development, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to define requirements and recommendations for complex system and facility modifications.
- Partner with Project Managers to execute engineering projects within established timelines, budgets, and quality standards.
- Coordinate activities performed by consultants, architects, contractors, and external engineering firms.
- Support the development and management of departmental and project budgets.
- Prepare and review engineering design documentation, specifications, technical reports, and project deliverables.
Education Requirements
Candidates must meet one of the following education and experience combinations:
- Doctorate Degree in Engineering; OR
- Master's Degree in Engineering with a minimum of two (2) years of engineering experience; OR
- Bachelor's Degree in Engineering with a minimum of four (4) years of engineering experience.
Required Knowledge, Skills, and Abilities
Technical Competencies
- Working knowledge of pharmaceutical and biotechnology manufacturing processes.
- Familiarity with equipment qualification and validation processes.
- Experience working within highly regulated environments.
- Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Ability to apply engineering principles to manufacturing and production operations.
- Experience with validation protocol execution and lifecycle management.
- Ability to operate specialized laboratory equipment and computerized systems.
- Strong technical documentation and report-writing skills.
Engineering & Problem-Solving Skills
- Strong analytical and troubleshooting capabilities.
- Ability to develop effective solutions to technical issues of varying complexity.
- Experience applying scientific and engineering principles to investigate and resolve operational challenges.
- Ability to independently assess situations and determine when additional internal or external resources are needed.
- Demonstrated expertise in multiple engineering disciplines or technologies.
- In-depth understanding of equipment validation processes associated with new equipment installations.
Communication & Collaboration
- Strong verbal and written communication skills.
- Effective technical presentation skills.
- Ability to collaborate with cross-functional teams and stakeholders.
- Strong interpersonal skills with the ability to work effectively across diverse communication and work styles.
- Proven facilitation, negotiation, and conflict resolution abilities.
Project Management Skills
- Experience managing multiple projects simultaneously.
- Schedule development and project planning expertise.
- Ability to prioritize competing business needs and meet deadlines.
- Knowledge of project budgeting and cost management.
- Experience tracking project deliverables through completion and follow-up.
- Understanding of financial analysis tools and business decision-making processes.
Leadership & Organizational Skills
- Ability to lead and coordinate technical teams.
- Experience delegating and managing project assignments.
- Strong organizational and change management skills.
- Leadership and team-building capabilities.
- Experience managing contractors, consultants, and vendors.
- Ability to influence stakeholders and drive project execution successfully.
Why Join This Opportunity?
This position offers the opportunity to contribute to high-impact engineering projects, collaborate with cross-functional teams, and play a key role in supporting manufacturing excellence, compliance, and continuous improvement initiatives within a highly regulated environment.
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