Senior Process Engineer

Sr. Process Engineer Biomanufacturing & Facilities Support

Location : Massachusetts (On-Site)

Duration : 12-Month Project-Based Contract

Position Summary

Pioneer GMP Consulting is seeking an experienced Sr. Process Engineer with 37 years of biomanufacturing or pharmaceutical engineering experience to support a global drug manufacturer in Massachusetts. This role focuses on equipment reliability preventive maintenance execution troubleshooting and support for validation and operational readiness activities in a cGMP environment.

The ideal candidate brings strong technical problem-solving skills a solid understanding of manufacturing and analytical systems and the ability to collaborate across Quality Supply Chain Automation Engineering and Validation teams to maintain compliant and efficient operations.

Key Responsibilities

Execute and document preventive maintenance work orders engineering assessments and equipment evaluations.

Diagnose and resolve equipment- and system-related issues across biomanufacturing and analytical operations.

Review supplier change notifications and assess equivalency of components or replacement parts.

Provide on-floor support for validation and maintenance protocols including data collection and execution oversight.

Update and maintain engineering drawings specifications and component lists.

Conduct audit trail reviews and manage system user access in accordance with site procedures.

Support deviation investigations root cause analysis and CAPA development.

Participate in daily / weekly operational meetings and rotate through site support responsibilities.

Required Skills & Experience

37 years of process engineering experience within a cGMP biopharmaceutical pharmaceutical or biotechnology environment.

Strong understanding of engineering fundamentals equipment troubleshooting and preventive maintenance programs.

Proficiency in root cause analysis and data evaluation (e.g. Excel control charts).

Ability to read and interpret P&IDs engineering drawings and single-use component diagrams.

Familiarity with systems such as Veeva Siemens COMOS IBM Maximo OSIsoft PI Trackwise and Microsoft Office.

Effective cross-functional communication and collaboration skills.

Qualifications

Bachelors degree in Chemical Mechanical Biochemical Engineering or a related engineering / science discipline.

Demonstrated experience supporting equipment reliability process operations or facility readiness in regulated environments.

Experience working with validation teams quality systems and risk-based assessments.

Ability to manage individual tasks while contributing to cross-functional project execution.

Preferred Qualifications

Experience supporting large-scale facility startup equipment onboarding or process technology transfer.

Exposure to bioprocess systems utilities or laboratory equipment troubleshooting.

Experience with digital systems related to asset management manufacturing data or document control.

Compensation & Benefits

Competitive hourly / salary rates commensurate with experience. Travel and per diem allowances may apply depending on assignment.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race color religion sex sexual orientation gender identity national origin age disability veteran status or any other protected category under applicable law.

Key Skills

Distributed Control Systems,Continuous Improvement,Process Improvement,Minitab,Root cause Analysis,Tooling,Statistical Software,Process Engineering,cGMP,Programmable Logic Controllers,Public Speaking,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1