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Senior Engineer (Bio-Pharma Industry)

Company:
ProQualityNetwork
Location:
Juncos
Pay:
45USD - 48USD per hour
Posted:
July 25, 2025
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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 Verifier

QMTS Deviation Initiator, Change Control Owner

GDMS Owner

Participate in or lead the development, review, and approval of:

Work Orders (WOs)

Change Controls and CAPAs

User Requirement Specifications (URS), Design Specifications (DS), Risk Documents (RD)

Maintenance Master Packages (MMP)

Test Runs, Protocols (PTC), FATs/SATs, Functional Tests, IOQ/PQ

P&IDs and other technical drawings

SOPs and Forms (author, reviewer, owner)

Job Plans and Spare Parts maintenance documentation

Operational 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 OR

Masters degree in Engineering with at least 2 years of relevant experience OR

Bachelors degree in Engineering with a minimum of 4 years of relevant experience

Core Competencies & Technical Skills

Strong knowledge of biopharma manufacturing processes

Familiarity with validation protocols and regulated documentation systems

Ability to operate and support specialized laboratory or manufacturing equipment

Applied understanding of GLP, GMP, and FDA regulations

Problem-solving skills with a scientific and engineering approach

Technical writing and presentation capabilities

Experience in protocol writing, execution, and report generation

Skilled in managing change, project scheduling, and cross-functional collaboration

Additional Competencies (Preferred)

Expertise in:

Validation lifecycle processes for new equipment

Technical negotiation and vendor management

Project budgeting and cost tracking

Conflict resolution and team leadership

Financial analysis tools

Training development and delivery

Ability to manage multiple complex projects simultaneously

Effective collaboration with a wide range of stakeholders and departments

If 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.

Full-time

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