PCI Pharma Services

Compliance

• Write and implement procedures according to the current Code of Federal Regulations.
• Assure that company policies are properly followed and applied by all appropriate personnel.
• Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation.
• Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports.
• Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act.
• Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific.
• Review and maintain appropriate Site Master Files.
• Manage and monitor Audit Corrective Actions.
• Write audit responses pertaining to customer and/or internal observations, and track completion of actions.
• Review investigations associated with DEA Controlled Products.
• Submit applicable registration applications.
• Prepare and present monthly Clinical metrics including Customer specific and overall departmental values.

Clinical Regulatory Affairs Specialist – Level 2

QA Engineer

• Plan, develop, implement and monitor the equipment and process validation strategy for PCI’s Advanced Drug Delivery business
• Partner with internal team members to ensure successful design/tech transfer with NPI by supporting or driving validation processes with appropriate risk management leadership
• Responsible for supporting all phases process qualification, ensuring product production according to established control plan, design and product specifications
• Drive continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality
• Interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed
• Develop and implement product and process workflows to ensure best engineering practices

Quality Engineer – Sustaining Engineering

Analyst

• Design, build, and maintain Smartsheet solutions.
• Work closely with the Smartsheet Program Manager.
• Support Power BI by managing acceptable use cases and ensuring data governance.
• Serve as the first line of support for Smartsheet users.
• Conduct onboarding and training sessions for new users and teams.
• Manage user licenses, permissions, and workspace configurations.
• Create and maintain user guides, SOPs, and training materials.
• Work cross-functionally with IT, operations, and business teams.

Analyst, Smartsheet Success

Human Resources

• Effectively working with the team to prioritize work and establish a strong partnership with HR to ensure clear governance in how value is delivered to the end users with the goal of providing an amazing employee experience
• Demonstrate ability to provide Tier 1 & Tier 2 user support, troubleshooting, and education to HRIS users, primarily HR team members
• Partners with HR team members in business process enhancements
• Assist in the review, testing and implementation of upgrades or patches
• Support in the maintenance and updating of the HRIS database, including employee records, organizational structures, job profiles, and other relevant data
• Serve as a primary point of contact for HRIS related inquiries by way of the internal ticketing system and appropriately assign tickets to WD support team members
• Partner with cross-functional team members and HR on HRIS-related issues/enhancements/queries
• Participate and contribute to the pro-active review and implementation of process improvements to ensure enhancement of user experience and improve data management
• Communicate and partner with key external vendors as needed
• Generate standard and ad-hoc reports, dashboards, and analytics to support HR and business decision-making
• Assist in developing and maintaining regular reporting processes to provide timely and accurate data to stakeholders
• Assure data integrity of internal HR systems and databases; monitor system access and user permissions to safeguard sensitive HR data
• Provide ad-hoc operational support, special programs and initiatives as needed

Workday HR Systems Specialist II

Data Engineer

• Design, build, and maintain scalable, reliable and cost-efficient data pipelines to support analytics, machine learning, and operational use cases
• Lead data engineering initiatives that support AI/ML model development, deployment, and scalability across enterprise platforms in alignment with business priorities
• Manage and optimize data ingestion, transformation, and storage processes across structured and unstructured data sources ensuring high data availability and performance
• Administer and maintain data tools and platforms (e.g., Databricks, Airflow, dbt, Kafka) to ensure high availability and performance
• Collaborate with a data platform partner or vendor to implement, integrate, and evolve platform capabilities aligned with business needs
• Ensure data quality, integrity, and consistency through robust validation, monitoring, and alerting mechanisms
• Implement and enforce data governance, security, and compliance standards in collaboration with relevant stakeholders
• Monitor and optimize data infrastructure costs, performance, and scalability in cloud and hybrid environments
• Develop and maintain documentation for data architecture, pipelines, and processes to support transparency and knowledge sharing

Director, Data Engineering

Project Manager

• Responsible for commercial packaging New Product Introduction (NPI)
• Support the generation of quotations for new business
• Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP, technical standards, procedures and systems
• Monitor, control and report on the project management elements of the NPI CER budget
• Drive a Right First-Time culture within operations to deliver a Zero-Defect performance

NPI Project Manager

Director

• Serve as a key leader and operational driver of a global total rewards framework
• Lead the design, oversight, and implementation of compensation, benefits, and leave programs
• Work closely with executive leadership to ensure compensation and benefits programs support organizational priorities
• Lead the global compensation philosophy, job architecture, and pay structures
• Oversee job evaluations, market benchmarking, and classification frameworks
• Direct annual compensation planning cycles, including merit increases and short-term incentives
• Optimize the Workday Advanced Compensation module
• Advise senior leadership on pay transparency and wage compliance
• Develop and continuously improve global benefits programs
• Provide strategic consultation to executive leadership and HRBPs on benefits design
• Lead vendor management, including RFPs and contract negotiation
• Oversee all global leave of absence and accommodations programs

Senior Director, Global Compensation and Benefits

Engineer

• Consult with Engineering team on maintenance requirements and Preventative Maintenance work.
• Troubleshooting on Facilities issues.
• Manage and maintain all facilities, utility, equipment, and grounds.
• Review and develop plant upgrade / modification proposals.
• Management and contribution of the maintenance system for the Facilities Engineering Group.
• Ensure that all Building Repairs and Upgrades are maintained to Pharmaceutical Standards.
• Ensure that the facilities documentation is completed, maintained, and reviewed accordingly and in compliance with all GMP guidelines.
• Manage Contracts: Utilities / Security / Cleaning / Pest Control / Landscaping / Fire Protection / Security Alarms / Camera’s / Access control / garments and Waste Management.
• Control of Facility Engineering contractors including pre-qualification, site entry, induction, permit to work, method statements, LOTO, work inspections and exit from site.
• Identify and implement measures to affect savings in all energy costs.
• Updating relevant SOP’s, documentation, and technical papers.
• Implementation of recycling initiatives.
• Liaise and work with the Facilities Engineering team to ensure that all plant related duties are successfully conducted.
• Drive Continuous Improvement initiatives (TPM, Lean, 6 Sigma, Shingo…).
• Assist and in cases lead technical improvements under the department’s continuous improvement program.
• Plan and manage small/ medium capital projects in the department to successful completion.
• Work closely with the H&S Department to ensure that all relevant environmental and safety requirements in the plant are met.
• Perform Validations as required on various Facilities systems.
• Manage all relevant maintenance/facilities budgets.
• Coordinate the implementation of remedial actions identified in audits.
• Work with PCI Engineering teams on various Facilities related projects.
• Work in close collaboration with other related functions to deliver required outputs on a 24/7 shift basis.
• Work closely with Site stakeholders to successfully deliver outputs and capacity enhancement projects.
• Provide technical support for new product introduction and product transfers.
• Address and effectively manage documentation issues arising from engineering activities.
• Work in close collaboration with equipment vendors to address any performance issues.
• Defining, controlling, and documenting engineering operations practices.
• Leading risk assessments and gap assessments for new processes, new equipment, and modified equipment.
• Lead and Attend Daily Handover meetings to review issues or by delegation where required.
• Organise and supervise outside contractors i.e. calibration / service contracts / cleaning.
• Maintain high standards of cleanliness, hygiene and GMP.