Sr. Manager, Engineering

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:

The senior manager is accountable for all aspects of Engineering, Instrumentation & Controls, and Metrology in supporting pharmaceutical product manufacturing across the PCI Madison, WI site. The senior manager provides leadership to ensure the highest level of quality and adherence to cGMPs across the 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 and calibration. Additionally, responsible for management of site CAPEX projects and acts as site representative for PCI’s Environmental, Social, and Governance (ESG) program.

Essential Duties and Responsibilities:

• Ensures all aspects of engineering are adhering to cGMPS and PCI’s established SOPs. Makes the necessary recommendations and changes to improve process efficiencies.
• Ensures all projects are executed safely, on time, and within budget.
• Identifies, prepares and leads site CAPEX projects.
• Responsible for all aspects of Engineering and maintenance programs.
• Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects.
• Instill a strong culture of Lean and Continuous Improvement through the use of 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 supports manufacturing operations in a fashion that focuses on quality and adherence to the schedule in support of Operations
• Assures compliant and timely completion of all quality documents (Deviations, CAPAs, Change Controls, etc) assigned to the Engineering team.
• Support a variety of regulatory and client audits.
• Ensures team training and performance compliance with all corporate policies and procedures.
• Provides guidance to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, and investigations related to engineering areas.
• 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 determines modifications necessary to improve safety, as needed and streamline processes.
• Responsible for on time calibration schedules for Madison site.
• Advanced knowledge and understanding of PLC programming and integration that support GMP automated system, vial transport equipment, clean utilities, sterilization equipment, and lyophilizers.
• Supports Continuous improvement activities tied to budget goals and helps lead key ESG initiatives.
• Directs assigned personnel, including performance evaluations, scheduling, orientation and training. Recommends employee hires, transfers, promotions, salary changes, discipline, termination and similar actions, as appropriate.
• Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities.
• Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships (internal and external).
• Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities.
• Part of the Site Leadership Team (SLT).
• Performs other duties as assigned.

Qualifications:

• Bachelor’s degree in engineering discipline preferred. 
• Master’s degree in engineering or business administration preferred.
• Operational background in cGMP environment, preferably in aseptic manufacturing/engineering.
• Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources.
• Experience in working with regulators during inspections/audits is highly desired.
• 8+ 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 support to biopharma/pharm and/or medical device facilities.
• 5 years of experience managing subordinate people leaders with accountability for objectives and subsequent evaluation.
• Experience with company financial systems and an understanding of accounting practices and financials a plus.
• Experience with direct exposure to Customers in a CDMO business is a plus.
• Demonstrate commitment to continuous improvement at all levels within the organization.
• Excellent organizational skills
• 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 assess and develop organizational talent which includes engaging employees and driving technical and personal development.  Setting future leadership for success.
• Performance measurement and KPI Tracking and Reporting
• Proficiency with MS Office suite is preferable.
• Possess advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment.
• Leads by example to motivate and engage through clear communication, of vision and goals.
• Demonstrates resilience and takes a proactive approach to change management to enable leaders to drive the change successfully.
• Effective verbal and written communication with both internal and external contacts is critical to success
• Set a clear vision and direction for the reporting functions, encouraging communication and a team-based approach.
• <10% domestic and some international

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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.