Process Engineer

Description:

Overview

ValSource is currently looking to identify experienced and technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network. This is a key part of strengthening ValSource's role in front-end Engineering and enabling end-to-end support for our clients.

Responsibilities

We are seeking passionate, energetic leaders with strong initiative to support our clients’ Process Engineering programs within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used in these environments.

Responsibilities include, but are not limited to:

- Reporting to the clients Process Engineering or Area Manager, while demonstrating independent drive and sound judgment in day-to-day operations at the client site.

- Collaborating closely with client teams and internal staff to act in the best interest of the client.

- Lead the project through an offsite design effort (at the Design partner’s location), to onsite installation and execution at the Client site.

- Manage multidisciplinary teams with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management phases from Concept Design, through Detailed Design and Execution.

- Provide clear technical leadership and expertise to lead teams through Safety assessments (PHA, HAZOP and LOPA) and Quality assessments (Development of CIP/SIP strategy, Automation development and GMP Design review). Gather internal and external stakeholder requirements and communicate clear owner's intent, ensure stakeholders are aligned or if not, escalate issues for rapid decision making.

- Collaborate strongly with client Subject Matter Experts (SMEs) for critical design decisions.

- - Demonstrate strong organization, technical writing and communication skills. Coordinate succinctly and effectively with the management and reporting team to drive clear and timely decision making.

- Manage quality, schedule and cost within prescribed project limits.

Ensure the thorough completion of the following process-specific activities:

- Vendor collaboration: build productive relationships to deliver complex equipment in a timely manner.

- Listen and translate clients' operational requirements to a hard design; document these needs in User Requirements and Equipment Specifications to onboard a Vendor.

- Review vendor design specifications and submittals to ensure compliance with client requirements and industry best practices in the physical design.

- Ensure clear communication and prioritization of needs for Structural, Civil, HVAC, Electrical & Construction groups.

- Lead FAT execution at Vendor sites, representing the client. Act as facilitator, supervisor and Safety lead ensuring client Safety and Quality standards are upheld.

- Lead and oversee Execution phase for the Process Team with CQV team, ensuring thorough testing of all requirements and demonstration of system functionality.

Requirements:

Location: Conshohocken, PA & Holly Springs, NC

Project Duration: Through Performance Qualification (PQ) Phase

Travel: Required between Conshohocken, PA and Holly Springs, NC

We are seeking several experienced Process / Process Equipment Engineers to support a major pharmaceutical manufacturing project. These individuals will act as Owner’s Representatives throughout the full project lifecycle—from design and installation through commissioning, qualification, and startup.

Initial project work will be located in Conshohocken, PA (suburb of Philadelphia) for 6-12 months with an eventual transition to on-site in Holly Springs, NC for 2+ years.

Key Responsibilities

Project Oversight & Support

Serve as Owner’s Representatives for the following areas:

- Compounding/Formulation Systems

- Component and Stopper Preparation (washers, autoclaves, stopper processors)

- Syringe Filling Equipment

- Automated Visual Inspection Systems

- Autoinjector Assembly Equipment

- Secondary Packaging Lines

Leadership & Collaboration

- Lead cross-functional teams across engineering, quality, validation, and operations.

- Collaborate with Jacobs project teams and internal stakeholders to ensure alignment of design, installation, and qualification with Owner’s requirements.

- Bring in internal SMEs as needed to address specialized technical issues.

Alignment & Communication

- Proactively gather and clarify stakeholder requirements.

- Clearly communicate Owner’s intent to project teams.

- Facilitate alignment across disciplines; escalate unresolved issues for timely resolution.

Execution & Accountability

- Ensure all assigned equipment areas meet project safety, quality, schedule, and cost targets.

- Drive results—anticipate challenges, resolve issues independently, and ensure discipline deliverables are achieved in full, on time, and on budget.

- Take ownership and accountability for area performance through all project phases.

Candidate Qualifications:

- Bachelor’s degree in engineering or related field.

- Minimum of 6-8+ years of experience in pharmaceutical or biotech manufacturing projects.

- Strong working knowledge of GMP systems, equipment qualification, and process operations.

- Proven ability to lead teams, manage stakeholders, and drive performance across disciplines.

- Excellent communication, problem-solving, and organizational skills.

- Willingness to travel and spend time at both Conshohocken and Holly Springs locations.

Other information

This is a full-time position with ValSource. As such, we are not considering applications from employment agencies, independent contractors, or third-party vendors.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Benefits

Benefits of full-time employment with ValSource will include:

- Paid Time Off (PTO) and Holidays

- Medical / Dental / Vision Insurance - premiums 100% paid by ValSource for Employee to Family level coverage

- Basic Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages

- ValSource 401(k) Plan

- ValSource Employee Stock Ownership Plan (ESOP)

- Paid Maternity / Paternity

- Medical Leave Pay

- Tuition Reimbursement / Continuing Education

- Annual Performance Bonus Compensation

About ValSource

ValSource is one of the largest independent Validation Services Company in North America with over 350 Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.

Equal Employment Opportunity

ValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.