Job Description:

As Senior Process Engineer you will be responsible for providing advanced engineering support for pharmaceutical manufacturing equipment and processes within a cGMP-regulated environment. This role leads and executes complex technical projects, supports capital equipment initiatives, and ensures successful design, commissioning, qualification, and integration of equipment and systems. The Senior Process Engineer collaborates with cross-functional teams-including Manufacturing, Quality, Validation, Automation, and Regulatory Affairs-to maintain compliant and reliable operations, drive continuous improvement, and support regulatory inspections.

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.

Requirements:

• 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.

Physical Requirements:

• 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.

Role will be in Parsippany, NJ.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $120,000 to $138,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. If hired to work 2nd in this role, the pay differential will be 10%. If hired to work 3rd shift in this role, the pay differential will be 20%. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 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 as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

Location:
Parsippany, New Jersey