Job Description
Job Description
Job Title : Senior Engineer (Bio-Pharma Industry)
Location : East Region, Puerto Rico
Work Schedule : 100% Onsite | Administrative Shift (8 : 00 AM 5 : 00 PM)
Duration : Approximately 1 year
Positions Available : 1
Position Summary
Our client, a leading organization in the biopharmaceutical industry, is seeking a highly experienced Senior Engineer to support ongoing capital projects, process optimization, and operations initiatives. This role involves the independent development, execution, and oversight of complex engineering tasks related to facility systems, utilities, and equipment. The engineer will also play a critical role in troubleshooting operational issues, driving continuous improvement, and ensuring full compliance with regulatory and company standards.
This position requires direct interaction with cross-functional teams including Manufacturing, Facilities, Quality, Validation, and Engineering, making it ideal for candidates who thrive in fast-paced, regulated environments.
This position offers an exciting opportunity to contribute to a high-impact project in the biologics manufacturing industry. The ideal candidate will possess strong engineering expertise, project leadership capabilities, and a solid understanding of regulated environments.
Key Responsibilities
General Engineering Functions
- Lead complex or novel engineering assignments requiring development of new techniques and approaches.
- Develop engineering policies and procedures impacting multiple departments.
- Supervise and coordinate the work of engineers, associates, and technicians.
- Apply advanced engineering methods both within and outside of primary discipline.
- Provide mature engineering insights to support planning and execution of projects.
- Serve as a peer-recognized technical expert in at least one area of engineering.
- Deliver practical solutions to a wide range of technical problems involving facility and equipment systems.
Design & Project Engineering
Develop technical solutions to complex system design and modification needs.Collaborate with departments such as R&D, Manufacturing, Quality, and Validation to define technical requirements.Lead or support design and engineering projects to meet schedule, budget, and quality targets.Coordinate with architects, consultants, and engineering firms to develop design documentation.Contribute to the development of project or departmental budgets.System and Documentation Responsibilities
Develop prequalification documentation and support the creation of protocols, including EHS and Out-of-Process (OOP) Risk Assessments.Execute equipment qualification activities per system category (A, BCal, BQual, C).Provide oversight to contractors with laboratory equipment validation experience, including testing of Water for Injection (WFI) systems and related assets.Act as system owner in applicable company platforms, including :MAXIMO Requestor, Approver, Executor (RSO)CDOCS Editor, Owner, Reviewer, Approver, Data VerifierQMTS Deviation Initiator, Change Control OwnerGDMS OwnerParticipate in or lead the development, review, and approval of :Work Orders (WOs)Change Controls and CAPAsUser Requirement Specifications (URS), Design Specifications (DS), Risk Documents (RD)Maintenance Master Packages (MMP)Test Runs, Protocols (PTC), FATs / SATs, Functional Tests, IOQ / PQP&IDs and other technical drawingsSOPs and Forms (author, reviewer, owner)Job Plans and Spare Parts maintenance documentationOperational Support & Continuous Improvement
Troubleshoot technical issues and provide recommendations to prevent recurrence.Analyze equipment failures and downtime; create and implement corrective action plans.Lead root cause analyses and support high-skill equipment breakdown responses.Participate in and support Kaizen events, risk assessments, critiques, and Value Stream Mapping (VSM) sessions.Develop and deliver technical training and one-point lessons for systems and equipment.Identify, evaluate, and implement process and equipment improvement initiatives.Author, execute, and implement CAPAs.Education Requirements
Doctorate in Engineering ORMasters degree in Engineering with at least 2 years of relevant experience ORBachelors degree in Engineering with a minimum of 4 years of relevant experienceCore Competencies & Technical Skills
Strong knowledge of biopharma manufacturing processesFamiliarity with validation protocols and regulated documentation systemsAbility to operate and support specialized laboratory or manufacturing equipmentApplied understanding of GLP, GMP, and FDA regulationsProblem-solving skills with a scientific and engineering approachTechnical writing and presentation capabilitiesExperience in protocol writing, execution, and report generationSkilled in managing change, project scheduling, and cross-functional collaborationAdditional Competencies (Preferred)
Expertise in :Validation lifecycle processes for new equipmentTechnical negotiation and vendor managementProject budgeting and cost trackingConflict resolution and team leadershipFinancial analysis toolsTraining development and deliveryAbility to manage multiple complex projects simultaneouslyEffective collaboration with a wide range of stakeholders and departmentsIf you meet the qualifications and are ready for your next professional challenge, we encourage you to apply by submitting your updated resume through the link in this job description.
