Head of Engineering, Sterile Injectables

Rochester, Michigan

Full time

R003428

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

The Senior Director of Engineering provides strategic, technical, and operational leadership for all engineering-related functions supporting a state-of-the-art aseptic fill-finish pharmaceutical manufacturing facility. This role is accountable for the reliability, compliance, performance, and continuous improvement of manufacturing equipment, automation systems, facilities, utilities, and technical infrastructure necessary to support cGMP operations.

As a key member of the Sterile Injectables Operations Leadership Team, the Senior Director will develop and execute the Rochester site's engineering strategy and site master plans to support long-range growth business growth, regulatory compliance, operational excellence, regulatory compliance, and capacity expansion while fostering a high-performance culture focused on safety, quality, and customer service. This role creates and embeds appropriate engineering standards across manufacturing operations, ensures efficient spending processes in the areas of capital equipment, engineering, and construction services, and builds technical capability within the site engineering teams to align resources and maximize delivery to the business.

The position oversees Engineering, Automation, Maintenance, Reliability, Facilities, Utilities, and Capital Projects and serves as the technical steward for all manufacturing infrastructure supporting production operations.

Job Description

Key Responsibilities

Engineering & Technical Leadership

• Develop and execute the site engineering vision, strategy, and long-range plans aligned with business objectives.

• Lead a multidisciplinary organization responsible for engineering, maintenance, facilities, utilities, reliability, automation, and project execution.

• Establish engineering standards, governance processes, and best practices across the site.

• Serve as a strategic partner to Manufacturing Operations, Quality, Supply Chain, Technical Operations, EHS and Engineering functions across Par Health.

• Drive operational excellence initiatives focused on productivity, asset utilization, and manufacturing performance.

• Build Engineering organizational capability through talent development, coaching, succession planning, and leadership development

Operations

• Accountable for overall area performance across safety, quality, delivery, and cost

• Defines staffing strategy and long-term resourcing plans to support business needs

• Makes strategic operational decisions within defined authority to optimize performance and capacity

• Sponsors production system governance and drives operational maturity

• Ensures systems and processes support sustained housekeeping and operational standards

Compliance & Quality

• Accountable for overall compliance posture and sustained inspection readiness

• Governs aseptic strategy and proactively manages compliance risk

• Accountable for overall QMS performance and effectiveness across the area

• Reviews, approves, and governs procedures to ensure compliance and alignment with ALCOA data integrity principles

• Leads audit strategy and response; ensures sustainable and effective remediation

• Establishes and reinforces expectations for cGMP compliance and quality standards

Cross Functional Coordination

• Supports safety, health, and environmental policies and procedures

• Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are always met

• Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff (Safety by Design approach)

• Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments with all manufacturing locations

• Engages with Workforce development to ensure new and modified capital equipment procurement training, qualification, and certification modules are delivered in sustainable forum.

• Communicates directly with the operations departments to coordinate engineering program management activities

• Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures

• Actively participate and support relevant site teams and programs.

Plant / Process Improvement

• Communicates regularly with all Project Managers, Engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects

• Assists with planning and implementing plant improvements and expansions

• Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems

• Initiates and carries out projects that improve efficiency and/or reduce operating costs

• Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement

Leadership

• Owns staffing strategy, workforce planning, and organizational capability development

• Owns training effectiveness and ensures compliance with qualification requirements

• Accountable for performance management, including goal setting, development, and completion of contractual reviews

• Builds leadership capability within the team through coaching and development of supervisors

• Owns staffing strategy, workforce planning, and organizational capability development

• Owns training effectiveness and ensures compliance with qualification requirements

• Accountable for performance management, including goal setting, development, and completion of contractual reviews

• Builds leadership capability within the team through coaching and development of supervisors

• Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff

• Ensures that all engineering staff are trained on the most updated version of the operating procedures

• Provides technical mentoring for discipline engineers, maintenance managers, validation engineers at Par sterile Products manufacturing site

• Provide Mentorship to Operational Efficiency Program (OEP) teams at the Rochester Site

Minimum Requirements

Education

• Bachelor of Science in an engineering discipline; professional registration preferred. Advanced degree is desirable.

Experience

• 10 - 15+ years of progressive engineering leadership experience within pharmaceutical, biotechnology, or regulated manufacturing environments

• 10+ years supporting cGMP manufacturing operations.

• Significant experience in aseptic processing and sterile manufacturing environments.

• Demonstrated success leading engineering, maintenance, automation, facilities, and utilities organizations.

• Experience leading FDA, EMA, MHRA, and international regulatory inspections.

• Proven track record managing large-scale capital programs and facility expansions

Knowledge and Core Competencies

• In-depth knowledge of pharmaceutical plant operations is an asset

• Aseptic processing and contamination control

• Sterile injectable manufacturing

• Facility and utility systems

• Reliability engineering

• Automation and process control

• Validation and qualification

• Capital project execution

Skills and Abilities

The ideal candidate is a strategic and operational leader who combines strong engineering and pharmaceutical manufacturing expertise with exceptional people leadership skills. This individual will be a visible member of the Sterile Injectables Operations Leadership Team, capable of driving business results through technical excellence, disciplined execution, and a relentless focus on safety, quality, compliance, and operational performance.

Candidate will demonstrate the following leadership capabilities:

• Strategic thinking

• Executive presence

• Organizational development

• Change leadership

• Talent development and management

• Cross-functional collaboration

Additional skills:

• Requires a good understanding and experience in several engineering disciplines. Includes pharmaceutical facility design, and Drug cGMP’s on a global basis.

• Must have working knowledge of business planning

• Leads selection, development and assignment of engineering personnel required to implement business plans on a global basis, i.e. new processes, state-of-the-art designs/equipment, etc. The Engineering Department must look into the future to be able to provide the necessary skills to implement current and future long-range needs.

• Must have complete knowledge of project planning and management.

• Must have a thorough knowledge in several engineering disciplines and background information in others needed for project execution.

• Must be able to assist direct reports in the resolution of problems encountered in the technical areas of a project.

• Excellent oral and written communication skills

• Excellent organization and interpersonal skills

• Understanding of the Pharmaceutical industry including general knowledge of manufacturing, quality, and regulatory processes

• Demonstrated experience in managing individuals and teams

• Experience cultivating a team-oriented, collaborative environment

• Ability to elicit cooperation from a wide variety of sources, including upper management, team members, and other departments.

• Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities

• Proficiency in schedule, budget, resource, quality and communications planning, and execution

• Proficiency in Microsoft Office applications.

Physical Requirements

• Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds

• Climb ladders and work in high, precarious places up to elevations of 75 feet

• Regularly exposed to work near moving mechanical parts

• May be exposed to wet or humid conditions

• May be exposed to outdoor weather conditions

• Regularly exposed to high noise environments

• May be exposed to extremely dusty environments

• May be exposed to chemicals used in the manufacturing process

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Come join us! At Par Health, we believe great healthcare is built on getting the essentials right.

We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.