Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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.
JOB SUMMARY
Under the leadership of the VP, Global Engineering the Principal Project Engineer provides capital engineering and project support for all aspects of the design and construction of manufacturing facilities, either for new or modifications to and expansions of existing facilities.
Coordinate a series of activities, project tasks consisting of performing calculations, writing specifications, preparing bids, reviewing equipment proposals and evaluating or selecting equipment and preparing various lists, such as equipment and materials lists, and creating drawings such as electrical, piping and instrumentation diagrams, physical layouts and other drawings used in design and construction.
Also coordinate project design, cost estimates, schedule, interface with client, etc. on capital projects and other projects as suggested per Engineering management. The activities then transition to managing project implementation including oversight of selected vendors.
Determine specific customer and stakeholder requirements and manage communication across organizational and functional boundaries to assure that customers, peers, and support groups have a thorough understanding of the scope and deliverables for assigned projects.
JOB DUTIES
Support safety through personal engagement and promote individual accountability for safety.
Plan, supervise, and coordinate the activities and operations of assigned capital improvements projects.
Ensure the timely, accurate, and cost-effective completion of projects scope, schedule and budget.
Coordinate work of professional and technical projects through each project phase, with an emphasis on teamwork and collaborative problem resolution.
Ensure all phases of projects proceed on schedule and that contractors, utilities and other organizations involved provide support for Facilities, Systems, Utilities and Equipment, for the execution of projects/assignments from initial concept to final closeout of assigned projects.
Develop, monitor, and update integrated project plans and schedules so that projects can be executed in the most efficient manner possible. Facilitate project scheduling meetings and/or interactive planning meetings as required by the project team
Prepare baseline schedules and schedule basis documents for approval by project teams. Review schedules with project team members on a regular basis to ensure for accuracy and timeliness.
Assess impacts to the critical path and near-critical activities and report to the project team
Monitor scheduled deviations and variances and assist in the developing alternative methods for corrective action
Prepare and provide schedule progress reports, trending charts and schedule analysis on a periodic basis
Maintain record of scope changes, trends and variances that potentially affect schedule performance. Assure credibility of the information contained in the schedule
Review design plans and specifications for conformance to job requirements.
Prepare, develop, and check complex specialized contract provisions and design agreements.
Conduct pre-bid and pre-construction meetings detailing principle construction features and agreements.
Monitor project progress and conduct meetings to resolve problems and ensure timely completion. Participate in design meetings and implements agreements throughout the stages of the projects.
PROFESSIONAL SKILLS
Exceptional organizational skills with great attention to details.
Excellent communication skills both oral and written, Strong Technical writing skills
Highly developed interpersonal, skills to collaborate and effectively execute in partnership with many stakeholders
Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point,
Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices.
Ability to interpret and apply Federal, State, and local policies, procedures, laws, and regulations; supervise the preparation and maintenance of project documents and reports; communicate effectively and maintain effective working relationships
EXPERIENCE
Demonstrated success in Project management or closely related experience with Capital Project Management.
Experience and proficiency with Computerized Maintenance systems (CMMS), AutoCAD and SolidWorks
Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.
EDUCATION
BS in Engineering degree from an accredited university.
A minimum of 11 plus years’ experience in Construction, Engineering, Facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry.
QUALITIES
Effectively support internal and external relationships, key stakeholders and vendors.
Capable of quickly building rapport and proven success leading large cross functional teams
Hands on and agile to work in a fast paced CMO environment which required flexibility and adaptability.
Knowledge and experience with regulatory requirements, engineering principles, and construction techniques.
Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff. Strong communication skills.
Proven success working well in a team environment with flexibility to react to changing business needs.
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
Must be able to gown appropriately and lift and/or move up to 50 pounds
Must be able to walk or move about between locations
Must be able to sit or stand for prolonged periods of time
Able to work in a highly complex environment with competing demands and priorities
Proven ability to successfully manage multiple projects (duties) simultaneously
COMMUNICATIONS & CONTACTS
Interacts with and Works closely with Engineering, Manufacturing, MTS, Quality, EH&S, Facilities, and Validation
TRAVEL < 10% or >20%
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled