Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

This position is accountable for execution of Engineering related objectives within assigned projects/programs as defined by the Global Program Management Office (PMO). The Engineering Director, PMO will lead the global cross-site project engineering team as assigned to specific programs in achieving industry leading performance, ensuring deliverables meet established timelines within the appropriate cost structure. The role will be accountable for New Product/Process Transfer to Operations, Equipment & Facility Standards/Qualifications, Process Management/Equipment Standardization, and Tooling Management. This position will help lead the Biologics Expansion initiative across the PCI network. This position will collaborate cross functionally and with all levels in the organization to deliver overall project goals, implement improved systems/processes/equipment, and ensure site capability.

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):

• Develops and presents engineering (process/equipment/tooling/facility) options to meet customer requirements. Is a leader within the broader Global PMO team to assist customers in defining requirements and develops time-bounded project plans to assure timely execution.

• Provides input into capital plans for the project, including facility and production equipment to assure site production is in a position to meet business and regulatory requirements. Monitors actual spend v. budget to assure the engineering work for assigned projects are completed on-time and within budget.

• Leads the specification and selection of manufacturing equipment/utility equipment and contracts based on competitive bids and input of stakeholders. Oversees the equipment selection process and development of equipment/facility URS's

• Collaborates with PCI SMEs and supplier to develop conceptual and detailed designs and fabrication plans

• Instills a continuous improvement methodology to the PMO Engineering function

• Responsible for equipment and building commissioning and transfer packages

• Monitors, tracks, and reports key metrics (safety, quality, downtime, throughput, spending). Prioritize and guide assigned site engineering resources to identify and manage process/equipment improvements that optimize quality, service, reliability, and cost (labor and materials).

• Identifies and recommends site engineering staff to adequately resource/support through the life of the project. This could include working with engineering contractors and general contractors as needed.

• Develops and maintains engineering equipment and process standards to be utilized across the network.

• Collaborates with the local Training Manager to develop and provide technical training for all new equipment and processes.

• Prepares monthly reports to management detailing the status of open projects, including risks, recommendations and capital management.

• Collaborates with site project teams (Quality, Engineering, Ops, PM) to schedule and qualify project work.

• Utilizes formal project management tools to deliver and communicate all Engineering/Facility projects.

EDUCATION AND/OR EXPERIENCE:

BS Degree in engineering, 20+ years in manufacturing engineering

KNOWLEDGE/SKILLS:

Proficient project management skills

High level of facilities knowledge

Proven ability to achieve success in highly matrixed environment

Knowledge of cGMP facilities

Knowledgeable in business and financial principles

EXPERIENCE:

Experience with the acquisition, installation and operation of complex and/or automation equipment.

Experience with development and execution of validation protocols for process, equipment, cleaning, and computer systems in the pharmaceutical and/or medical device industry.

Project and program management

Technical transfer methodology

FDA/MHRA standards and audit

Operational experience as functional lead in major plant

PHYSICAL/MENTAL REQUIREMENTS:

Mathematical and reasoning ability

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Ability to work effectively under extreme pressure to meet deadlines.

Creative thinker with sound business judgment. Good negotiation and reasoning skills.

Excellent written and verbal communications skills. Ability to easily learn and retain technical information.

Well-honed problem solving skills, including innovative and creative solutions.

Well organized with ability to handle multiple activities simultaneously.

WORK ENVIRONMENT:

Travel as needed, up to 40%

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.