Process Engineer

Job Title: Engineer - Process & Quality

Job Description

The Sustaining Engineer supports the continued performance, quality, compliance, and lifecycle management of existing products within a regulated environment. This role 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. The Engineer also leads or supports validation efforts for product updates, enhancements, and line extensions, ensuring that all modifications meet design, quality, manufacturing, and customer requirements. By collaborating closely with cross-functional teams in Engineering, Quality, Operations, Supply Chain, and Regulatory, this position plays a key role in maintaining product continuity and driving continuous improvement in both products and processes.

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.

Essential Skills

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics/Polymer Engineering, or a related engineering discipline.
• 2 years experience
• 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.

Additional Skills & Qualifications

• 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 that supports 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.

This is a Permanent position based out of Southampton, PA.

The pay range for this position is $85000.00 - $95000.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 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)

This is a fully onsite position in Southampton,PA.

This position is anticipated to close on Aug 14, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $85,000 - $95,000