Sustaining Engineer

Actalent is seeking a Sustaining Engineer to support the continued performance, quality, compliance, and lifecycle management of existing products within a regulated environment.

About the role

The Sustaining Engineer ensures that products remain reliable, manufacturable, and aligned with applicable regulatory and quality standards through ongoing maintenance, engineering change evaluation, issue resolution, and verification activities. This role also leads or supports validation efforts for product updates, enhancements, and line extensions, ensuring all modifications meet design, quality, manufacturing, and customer requirements. The position collaborates closely with cross-functional teams in Engineering, Quality, Operations, Supply Chain, and Regulatory to maintain product continuity and drive continuous improvement.

Responsibilities

• Support the continued performance, quality, and compliance of existing products throughout their lifecycle.
• Ensure products remain reliable and manufacturable by monitoring performance and addressing technical issues as they arise.
• Evaluate engineering changes to existing products and processes, ensuring alignment with design intent, quality standards, and regulatory requirements.
• Lead or support issue resolution activities, including root cause analysis and implementation of corrective and preventive actions.
• Plan, execute, and document verification activities to confirm that product changes meet defined requirements and specifications.
• Lead or support validation activities related to product updates, enhancements, and line extensions to ensure changes are robust and compliant.
• Collaborate with cross-functional teams, including Engineering, Quality, Operations, Supply Chain, and Regulatory, to implement product and process changes effectively.
• Drive continuous improvement initiatives focused on product quality, manufacturability, and process efficiency within a regulated environment.
• Support lifecycle management activities, including documentation updates, risk assessments, and change control processes.
• Contribute to maintaining alignment with Good Manufacturing Practice (GMP) and other applicable regulatory and quality standards.
• Use CAD tools to support design changes, documentation updates, and engineering evaluations for existing products.
• Apply project management and leadership skills to plan, coordinate, and deliver sustaining engineering activities on time and within scope.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics/Polymer Engineering, or a related engineering discipline.
• 2+ years of hands-on experience in manufacturing engineering, with a focus on maintaining and improving existing products and processes.
• Proficiency in sustaining engineering activities, including change control, issue resolution, and lifecycle management.
• Experience working in compliance with Good Manufacturing Practice (GMP) standards.
• Proficiency with CAD tools to support design changes and engineering evaluations.
• Experience with validation activities for product or process changes in regulated industries.
• Strong project management and leadership skills to coordinate cross-functional sustaining initiatives.
• Ability to collaborate effectively with Engineering, Quality, Operations, Supply Chain, and Regulatory teams.

Skills

• Experience in process improvement initiatives aimed at enhancing product quality, reliability, and manufacturability.
• Familiarity with lifecycle management of products in Bio-Pharm, Medical Devices, or Life Sciences environments.
• Exposure to verification and testing methodologies for existing product changes.
• Ability to interpret and apply regulatory and quality standards to product and process changes.
• Strong analytical and problem-solving skills, including root cause analysis and corrective action implementation.
• Effective communication skills for working with cross-functional stakeholders and documenting engineering activities.

Work Environment

The Engineer works in a regulated manufacturing and engineering environment supporting products used in Bio-Pharmaceutical, Medical Device, or Life Sciences applications. The role involves close collaboration with Engineering, Quality, Operations, Supply Chain, and Regulatory teams to manage product changes and continuous improvement initiatives. Work typically takes place in a combination of office and production or laboratory settings where Good Manufacturing Practice (GMP) standards apply, and engineering tools such as CAD software are used regularly. The environment emphasizes compliance, documentation accuracy, and structured processes to support safe and reliable products.

Schedule

This is a Contract to Hire, fully onsite position based in Southampton, PA.

Pay

The pay range for this position is $85,000.00 - $95,000.00 per year.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)