Job Description
Our client is seeking an experienced Process Engineer to support a biopharmaceutical manufacturing facility. This individual will provide engineering support across manufacturing equipment, facility utilities, laboratory systems, and related infrastructure, while also supporting equipment projects, troubleshooting, investigations, and qualification activities.
This is a hands-on engineering role that will work closely with Manufacturing, Quality, Facilities, Validation, and other cross-functional teams. The ideal candidate has experience supporting equipment and utilities in a GMP/cGMP environment and is comfortable serving as a technical subject matter expert.
- Provide engineering support for a portfolio of manufacturing equipment, facility utilities, laboratory equipment, and support systems
- Serve as a technical subject matter expert for assigned equipment and systems
- Troubleshoot equipment and utility issues, identify root causes, and recommend corrective actions
- Support equipment-related deviation investigations, CAPAs, and change controls
- Provide technical input into preventive maintenance strategies and equipment reliability initiatives
- Identify and implement opportunities for equipment and process improvements
- Participate in engineering projects involving the design, procurement, installation, startup, commissioning, and qualification of new or modified equipment and systems
- Collaborate with Manufacturing, Quality, Validation, Facilities, and other internal stakeholders on equipment-related initiatives
- Work with external vendors, contractors, and equipment suppliers as needed
- Support equipment qualification and validation activities
- Prepare and review technical documentation, investigation reports, change controls, protocols, and other engineering documentation
- Ensure activities are performed in accordance with cGMP, SOPs, safety requirements, quality standards, and applicable regulatory expectations
- Support internal and external audits or regulatory inspections as a technical subject matter expert
- Maintain required training and documentation in a GMP-compliant state
Qualifications
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline
- 5–7+ years of professional engineering, facilities, manufacturing, or operations experience
- At least 3 years of experience in a cGMP environment preferred
- Experience supporting GMP manufacturing equipment and/or facility utilities
- Strong troubleshooting and root-cause analysis skills
- Experience with equipment qualification, validation, commissioning, or startup activities
- Familiarity with change controls, deviations, CAPAs, and GMP documentation
- Strong technical writing and documentation skills
- Excellent communication and interpersonal skills
- Ability to work independently while effectively collaborating within a cross-functional team
- Strong attention to detail, flexibility, and initiative
Preferred Experience
- Biopharmaceutical, pharmaceutical, or biologics manufacturing experience
- Experience with GMP utilities and manufacturing equipment
- Experience supporting facility or manufacturing expansion projects
- Experience with equipment commissioning and qualification
- Experience working directly with equipment vendors, contractors, and engineering partners
- Experience participating in regulatory inspections or GMP audits
- Master's degree in Engineering or a related technical discipline
Location: Framingham, MA
Schedule: 5 days onsite
Type: Contract opportunity
Numbers & Facts
| Location | Framingham, MA |
| Industry | Staffing/Employment Agencies |
| Company Size | 10 to 19 employees |
| Year Founded | 2017 |
| Website | http://www.whitecapsearch.com |
About Company
At WhiteCap Search we are breaking away from the traditional approach of agency recruiting to enhance the experience of the job search process. From companies looking to hire top talent, to job seekers looking for the best next step in their careers, WhiteCap Search is focused on finding the optimal fit for all parties involved.
Founded by a diverse team of recruiting experts, we have developed a strong foundational knowledge of each industry for which we recruit. We believe in combining best in class technology with rigid ethical standards to create a positive and tailored approach for each employer and job seeker.
The WhiteCap Search team is uniquely positioned to handle both permanent and temporary searches for a wide variety of job functions across all industries. We optimize our extensive network and cutting-edge technology to deliver results successfully and seamlessly. Utilizing our strong foundational knowledge of each industry for which we recruit, we engage our clients as partners by creating a customized plan for every search. We source job seekers proactively so that employers have unparalleled access to both active and passive job seekers. Our rigorous and consistent screening processes enable us to present top, qualified talent to our clients quickly, making the recruitment process as efficient as possible. Our temporary and consulting services provide employers and job seekers with flexibility. Whether it’s providing support during particularly busy times of the year, covering for an employee during a leave of absence or assisting with special projects, we can handle any of our clients’ temporary staffing needs. Additionally, our temporary-to-permanent staffing solutions provide both the job seeker and employer with the ability to evaluate whether they are the right fit for each other before making a long-term commitment.
Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Chemical Engineeringunmatched
- Commissioningunmatched
- Communication Skillsunmatched
- Corrective Actionunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Detail Orientedunmatched
- Documentationunmatched
- Engineeringunmatched
- Equipment Validationunmatched
- External Auditunmatched
- GMP (Good Manufacturing Practices)unmatched
- Identify Issuesunmatched
- Internal Auditunmatched
- Interpersonal Skillsunmatched
- Investigative Reportsunmatched
- Laboratory Equipmentunmatched
- Laboratory Systemsunmatched
- Manufacturingunmatched
- Manufacturing Equipmentunmatched
- Manufacturing Operationsunmatched
- Mechanical Engineeringunmatched
- Preventative Maintenanceunmatched
- Process Engineeringunmatched
- Process Improvementunmatched
- Project Designunmatched
- Purchasing/Procurementunmatched
- Quality Metricsunmatched
- Regulationsunmatched
- Root Cause Analysisunmatched
- Safety Trainingunmatched
- Standard Operating Procedures (SOP)unmatched
- Startupunmatched
- Technical Writingunmatched
- Writing Skillsunmatched
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