Reference #: JR107878Life 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.Summary of Objective:

　　The Global Engineer -Test Systems, is a subject matter expert in injection device testing methods, equipment, and work systems. The Global Engineer- Test Systems will be responsible for developing standards and best practices in the testing of Drug Device Combination products in all PCI sites. Additionally in this role, the Global Engineer- Test Systems will work with interdepartmental and cross functional teams consisting of automation engineers, quality engineers, and leaders to ensure we uphold the highest standards consistently across PCI sites manufacturing drug-device combination products. In working closely with clients and internal stakeholders, this position will evaluate new product opportunities, equipment vendors, skill set requirements by site and define a roadmap for success.

　　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.Lead working group to develop standards and best practices for testing methodologies, offline and online testing equipment, and deployment in PCI sites, working toward long-term vision by execution of annual working group objectives.Serve as a subject matter expert in applying the ISO 11040 and ISO 11608 specifications, work with business development, program management, and new clients to define equipment and testing requirements for receiving, in-process, release, and stability/functional testing  for DDC productsProvide subject matter expertise and hands-on work to integrate assembly and test during assembly equipment design, FAT, SAT, and validation to augment facility based NPI resources.Maintain an approved vendor list for testing equipment in conjunction with Procurement.Develop a skill set gap analysis for engineers and technicians in the testing spaceDevelop an ongoing training apparatus for our sitesUp to 20% of travelKnowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.Performs other duties as assigned by Manager/Supervisor

　　Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Independent leader, strong team leading skills, no direct personnel supervision. Liaisons with key stakeholders across the organization to realize successful outcomes.

　　Qualifications:RequiredBachelor's Degree in a related field and/or 3-5 years related experience and/or training.College Level Mathematical SkillsAdvanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.Ability to TravelStrong analytical and decision-making skillsExceptional time management, organizational, and negotiation skillsExcellent communication skills, written, verbal and strong presentation skills. Ability to motivate and lead teams by influence.Strong financial acumen and nalytical skills.Able to translate customer feedback into meaningful product solutions, is a self-motivated multitasker with high attention to detail.Track record in developing and executing product launchesEfficient with a focus on timelines & due datesKnowledge of GAMP5, ISO 11040, and ISO 11608 standards

　　Preferred:Work in experience in pharmaceutical, medical device, or related life sciences.

　　EQUAL OPPORTUNITY EMPLOYER/VETERAN/DISABLED

　　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.

　　LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.