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.

The Senior Engineer-Manufacturing Sciences and Technology (MTS) is responsible to define relevant operational/technical standards and practices for PCI sites that produce medical devices as well as the site and identify and drive implementation of improvements to maximize throughput and capacity utilization. The incumbent interfaces with other PCI functions as well as external clients to implement new processes and technologies into PCI GMP manufacturing as well as supporting validation efforts.

The Senior Engineer-Manufacturing Sciences and Technology (MTS) is a key contributor within a group responsible for performing process improvements, including timely completion of feasibility studies, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products/devices to pre-clinical, clinical and commercial manufacturing phases.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Actively participate and provide input and feedback for the PCI Safety Program to meet Health and Safety regulations and OSHA requirements in all duties
• Provide technical mentorship to junior Manufacturing Sciences and Technology (MTS) Engineers and investigators
• Experimentation and manufacturing support related work including development and pilot scale studies to support process development, optimization and characterization
• Contributes to the evaluation of novel, generic platform technologies that can be applied across multiple programs
• Active contributor in the technology transfer of programs spanning all phases of biopharmaceutical/medical device lifecycle, including discussions of scale, equipment design and oversight of GMP and Engineering batches. Establish technical support initiatives for GMP operations in these multi-product sites
• Interacts with manufacturing operations staff, troubleshoots problems and supports their operations
• Compose technical documents (protocols, batch records) for conducting technical studies
• Interpret and execute policies and procedures. Recommend modifications to operating policies
• Function as a technical expert on equipment, systems, processes
• Lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation (commissioning, protocols, test plans, functional/detailed design)
• Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS)
• Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications
• Coordinate the work of consultants and engineering firms on development of standard design documents
• Provides technical support to external clients and internal operations, utilizing statistical data analysis. Develops solutions to complex problems using ingenuity and innovation, and ensures solutions are consistent with overall organization objectives
• Drives key equipment, systems, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule and overall project performance
• Provide technical support and analysis for the resolution of deviations, investigations, and process issues
• May be directed to independently develop department procedures, standards, and specifications; write and review data summaries as per established company guidelines and procedures
• Authors technical reports, technology transfer packages and presentations
• Contributes to regulatory submissions. Develop project scopes, schedules and budgets

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Excellent oral and written communication skills
• Strong technical writing ability required
• Excellent interpersonal, teamwork, and leadership skills
• Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables.
• Ability to apply knowledge of multiple engineering disciplines to evaluate and develop solutions for operational issues.
• Proficiency with Microsoft products and ability to learn additional applications as needed
• Must be able to work on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors
• Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products
• Understanding of new manufacturing technologies including single use disposables
• Process Engineering/development experience in the biotechnology/pharmaceutical/medical device industry with practical expertise around scale-up, tech transfer and manufacturing support to large scale GMP operations is required
• Familiarity with the operation of large-scale disposable technologies, devices and production equipment for unit operations is highly preferred
• Proven track record of large-scale process implementation
• General understanding of fill finish, freeze drying (lyophilization), medical device, filtration, milling, mixing technologies, fluid metering, formulation, and purification
• Knowledge of equipment in pharmaceutical manufacturing including autoclave, filling pump, vial washer, depyrogenation oven, lyophilizers, and process utilities (WFI, PW, Clean Steam, HVAC, etc.).
• May supervise / mentor / lead and train less experience team members
• Manage MTS contractors as assigned

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
• Ability to gown and gain entry to controlled manufacturing areas.
• Ability to lift, pull or push equipment weighing up to 25-50 lbs.
• Occasional standing is required

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BS degree in an Engineering discipline with preference for Chemical of Life Sciences with 10+ years industry experience within a pharmaceutical, biotechnology/medical device or FDA/ISO regulated industry. Comparable blends of education and experience is acceptable.
• Resilient, can quickly move forward despite challenges
• A drive to achieve results while working with limited supervision
• Positive attitude and strong team, cross team collaboration
• Honesty, integrity, respect and courtesy with leadership and peers
• Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services

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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.