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.

JOB SUMMARY –

Accountable for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance in supporting pharmaceutical and medical device product manufacturing at the PCI Pharma Services Leon site.

This role is responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department.

Manages and oversees all areas of process engineering, automation, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations and non-aseptic medical device manufacturing activities. Additionally responsible for management of small CAPEX projects.

Reports to Vice President, Global Engineering.

JOB DUTIES –

• Ensures all aspects engineering and facilities are adhering to cGMPS and PCI’s established SOPs. Makes the necessary recommendations and changes to improve process efficiency.

• Ensures all projects are executed safely, on time, and within budget.

• Responsible for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance programs.

• Has primary responsibility for department representation supporting Regulatory Inspections and Customer Audits.

• Instill a strong culture of Lean and Continuous Improvement through the use the site maturity index

• Oversees the departmental budget and headcount.

• Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development.

• Provides leadership to ensure engineering and facilities support manufacturing operations in a fashion that focuses on quality and adherence to the maintenance schedule in support of Operations

• Directs general and specialized maintenance, small CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems, at all manufacturing, warehousing and office facilities.

• Ensures team compliance with all corporate policies and procedures.

• Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Global Engineering, and Global PMO to ensure internal and external clients’ requirements are met.

• Analyzes existing processes/unit operations and determine modifications necessary to improve safety, as needed and streamline processes.

• Directs and supervises assigned personnel, including performance evaluations, scheduling, orientation and training. Recommends employee hires, transfers, promotions, salary changes, discipline, terminations and similar actions, as appropriate.

• Correctly implements industry best practices that will withstand regulatory inspections by regulatory authorities.

• Responsible for administration of Computerized Maintenance Management System (CMMS) and maintenance planning.

• Part of the Site Leadership Team (SLT).

PROFESSIONAL SKILLS -

• Demonstrate commitment to continuous improvement at all levels within the organization.

• Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines

• Excellent verbal and written communication skills

• Ability to effectively manage multiple projects, teams and technical staff at all levels.

• Ability to manage teams in meeting deadlines.

• Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development.

• Capable of face-to-face interaction with Regulatory Inspectors and Customer Auditors resulting in positive outcomes.

• Performance measurement and KPI Tracking and Reporting.

• Proficiency with MS Office.

• English and Spanish are a must.

EXPERIENCE –

• Operational background in a cGMP environment and aseptic manufacturing/engineering is required.

• Experience with Regulatory Inspections/Customer Audits is required.

• 10-12 years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities.

• 8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation.

• 5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities.

• Experience with direct exposure to Customers in a CDMO business is a plus.

EDUCATION –

• Bachelor’s degree in engineering discipline.

• Master’s degree in engineering or business administration preferred.

QUALITIES –

• Possess advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment

• Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources.

• Leads by example to motivate and engage through clear communication, of vision and goals

• Demonstrates resilience and takes on a proactive approach to change management to enable leaders to drive the change successfully

Benefits

At PCI, we believe that our employees are our most valuable asset. That is why we are committed to offering a benefits package designed to support their well-being and improve their overall quality of life.

This is what we offer:

• Competitive salary

• Health insurance + % reimbursement for medications

• English classes

• Discounts on various activities

• Agreements with gyms

• Referral program

#LI-AT1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled