Senior Engineer – MSAT (NPI)

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.

Senior Engineer-MSAT

The Senior Engineer-MSAT role 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 MSAT Engineer 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 MSAT 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

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/or 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

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

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.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.