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 Title: Global Process Improvement Leader, Assembly Automation

Department/Group: Corporate- Administration

Location: North America (Remote Opportunity)

Reports to: Global Vice President- Engineering and Innovation

FLSA Status: Exempt

Summary of Objective:

The Global Process Improvement Leader, Assembly Automation, is a subject matter expert in high speed automation. The Global Process Improvement Leader, Assembly Automation will be responsible for developing standards and best practices in the automation space for all PCI sites. In this role, the Global Process Improvement Leader, Assembly Automation will work with engineers and engineering leaders to ensure we uphold the highest standards consistently across PCI sites manufacturing drug-device combination products.

Additionally, working closely with clients and internal stakeholders, evaluate new product opportunities, equipment vendors, and 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 automation standards and best practices for automation specification, build management, and commissioning in all PCI sites, working toward long-term vision by execution of annual Working Group objectives.
• 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 an approved vendor list for automation.
• Develop a skill set gap analysis for engineers and technicians in the automation space
• Develop an ongoing training apparatus for PCI sites
• Knowledge of and adherence to all PCI, cGMP, GCP policies, procedures, rules and regulations as applicable to assigned tasks.
• This position may require overtime and/or weekend work.
• 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 organizations 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 and strong team leading skills
• No direct personnel supervision.
• Liaisons with key stakeholders across the organization to realize successful outcomes.

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.

• Stationary Position: Under a 1/4 of the day.
• Move, Traverse: Up to 1/4 of the day.
• Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: From 1/4 to 1/2 of the day.
• On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

• This position may have the following special vision requirements.
• No Special Vision Requirements

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 Degree in a related field and/or 10+ years related experience and/or training.
• College Level Mathematical Skills
• 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
• 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 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.

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.