Senior Process Engineer - (1st/2nd/3rd shifts) jobs in United States
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Ferring Pharmaceuticals · 5 hours ago

Senior Process Engineer - (1st/2nd/3rd shifts)

Ferring Pharmaceuticals is a privately-owned biopharmaceutical company that delivers life-changing therapies. As a Senior Process Engineer, you will provide advanced engineering support for pharmaceutical manufacturing equipment and processes, lead complex technical projects, and collaborate with cross-functional teams to ensure compliant and reliable operations.

BiotechnologyManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Ensure adherence to all cGMP requirements, company policies, and standard operating procedures (SOPs)
Serve as a subject matter expert (SME) during internal and external audits, inspections, and regulatory interactions
Support Quality Assurance and Regulatory Affairs with preparation and review of documentation for change controls, submissions, and investigations
Support the design, fabrication, installation, and commissioning of new and modified manufacturing equipment
Develop and manage capital plans for equipment-related projects
Review and provide feedback on engineering documentation, including URSs, design packages, SOPs, FAT/SAT protocols, and IOQ documentation
Coordinate with equipment users, vendors, and external fabricators for project execution and equipment lifecycle management
Assist with integration of equipment into site networks, automation systems, monitoring systems, and data historians
Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
Participate in the development and review of validation protocols, engineering studies, and acceptance criteria
Provide technical troubleshooting for complex equipment and process issues related to aseptic systems, lyophilizers, and supporting utilities
Provide hands-on support on the production floor and in cleanroom environments as required
The position requires occasional off-shift support. On-call may be required (weekends, holidays)
Assist with programming, troubleshooting, and maintenance of programmable logic controllers (PLCs) and building/process monitoring systems
Collaborate with the Automation team to improve system reliability and data integrity
Lead and participate in risk assessments, including FMEAs, for new or modified equipment
Investigate equipment-related deviations and implement corrective and preventive actions (CAPAs)
Support and drive continuous process improvement initiatives across the site
Collaborate with internal teams and global sites on special projects and technical issue resolution
Plan and coordinate on-site activities for vendors, contractors, and service providers
Ensure timely and compliant execution of project deliverables
Willingness to provide on-call, off-shift, weekend, or holiday support as required to support production or project needs

Qualification

Pharmaceutical GMP experienceProcess designOptimizationEquipment commissioningQualificationData analysis tools proficiencyProblem-solving skillsCommunication skillsTechnical troubleshootingOrganizational skillsCollaboration skillsTime-management skills

Required

Bachelor's degree in Chemical, Mechanical, Industrial, or Process Engineering; equivalent experience (12+ years) may be considered in lieu of formal degree requirements
Minimum 7 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations
Demonstrated proficiency in process design, optimization, or troubleshooting
Completion of specialized training or certifications in process engineering or GMP manufacturing
Demonstrated experience in equipment design, commissioning, troubleshooting, and qualification
Strong analytical and problem-solving skills with the ability to apply engineering principles to complex systems
Proficiency in data analysis tools, automation interfaces, and quality systems software (e.g., deviation, CAPA, change control)
Excellent verbal and written communication skills
Strong organizational and time-management skills with ability to manage multiple priorities in a fast-paced environment
Ability to work collaboratively across functions and with external partners
Ability to work on-site in a manufacturing environment, including cleanroom areas as required
Must be able to stand and walk for extended periods of time while working on the production floor or in equipment areas
Ability to climb ladders or stairs and access elevated platforms or confined spaces as needed for equipment inspections or troubleshooting
Capable of bending, stooping, kneeling, or crouching to inspect or work on equipment
Must be able to lift, carry, push, or pull up to 25 pounds occasionally
Must be able to wear required personal protective equipment (PPE), including gowns, gloves, safety glasses, hard hats, and respiratory protection when necessary
Ability to tolerate occasional exposure to moderate noise, vibration, and temperature variations typical of manufacturing areas
Willingness to provide on-call, off-shift, weekend, or holiday support as required to support production or project needs

Benefits

Comprehensive healthcare (medical, dental, and vision) with a premium differential
401k plan and company match
Short and long-term disability coverage
Basic life insurance
Wellness benefits
Reimbursement for certain tuition expenses
Sick time of 1 hour per 30 hours worked
Vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment
15 paid holidays per year
Paid parental leave subject to a minimum period of employment at Ferring

Company

Ferring Pharmaceuticals

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Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives.

H1B Sponsorship

Ferring Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (1)
2022 (3)
2021 (2)
2020 (3)

Funding

Current Stage
Late Stage
Total Funding
$530.88M
2023-03-17Debt Financing· $530.88M

Leadership Team

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Valerio Trifoni
Senior Vice President Group Controlling
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Company data provided by crunchbase