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.

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.

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.