Global Commercial Assembly & Packaging Engineer

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.

Summary of Objective:

Global Commercial Assembly & Packaging Engineer, is a subject matter expert in high-speed automation with emphasis on device assembly and packaging. This position will be responsible for developing standards and best practices in the equipment and automation space for all PCI sites. This position will work with engineers and engineering leaders to ensure we uphold the highest standards consistently across PCI sites manufacturing drug-device combination products. Working closely with clients and internal stakeholders, this position will evaluate emerging technologies in the drug delivery device space, identify product opportunities, work with equipment vendors to implement new technologies to our equipment set, 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 engineering standards and best practices for assembly & packaging equipment specification, build management, and commissioning in all PCI sites.

• Strategic focus for equipment specific technology development is appropriate to the PCI CDMO working environment.

• Work with Business Development and new clients to define equipment and process requirements Provide subject matter expertise and hands-on work during equipment design, FAT, SAT and validation to augment facility-based NPI resources.

• Maintain Quarterly Business reviews for responsible OEMs and drive KPIs to best in class.

• Develop a skill set gap analysis for engineers and technicians in the equipment and troubleshoot high speed automation assembly and packaging equipment.

• Develop an ongoing technical training academy to enhance equipment knowledge for our sites, support troubleshooting and reduce mean to time to recovery on equipment issues.

• Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned tasks.

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position.

• Performs job 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 business leader, strong team leading skills, no direct personnel supervision.

• Liaisons with key stakeholders across the organization to realize successful outcomes.

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.

Required:

• Bachelor's or Master's degree in an Engineering discipline (Mechanical, Chemical, Electrical, Industrial, or IT equivalent technical field) is typically required.

• Approximately 10+ years of experience in strong pharmaceutical assembly and packaging equipment knowledge.

• Extensive experience of structured problem solving and troubleshooting techniques.

• Advanced 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 travel (Approximately 25%)

• Strong analytical and decision-making skills.

• Exceptional time management, organizational, and negotiation skills.

• Excellent communication skills, written, verbal and strong presentation skills.

• Ability to motivate and lead teams by influence.

• Strong financial acumen and analytical 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 new product launches.

• Efficient with a focus on timelines & due dates.

Preferred:

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

• Knowledge of GAMP5, ISO 11040, and ISO 11608 standards.

The hiring range for this position is $77,600 to $101,850 annually plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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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.