Overview:
The position leads the team responsible for the site facility and utility system maintenance and engineering activities supporting the drug substance operations. The drug substance operation is a new, approximately 460K sqft facility, being constructed to manufacture small molecule pharmaceutical active ingredients, oligonucleotides, and peptides. The individual will be a member of the Site Leadership Team, and will develop the team by applying a metric driven approach to establish a culture that aligns with the Company’s core values of integrity & dedication, working together, doing the right thing, and doing it right. Directly responsible for cost, schedule and resource estimates, targets and achievements. Ensures compliance with all Company, local, state, and federal policies and procedures for labor, safety, and quality.
Responsibilities:
- Overall responsible and accountable for site facility & utility system operation, maintenance and assets lifecycle management.
- Provides leadership and engineering guidance and allocates resources to support the successful execution of construction of the new facility along with future engineering projects.
- Develops and implements a maintenance and calibration program to meet regulatory requirements and maximize facility production.
- Develops and manages departmental and capital costs relative to engineering and facilities to meet established company goals.
- Applies sound engineering and project management principles in the procedural delivery of engineering projects.
- Manage both internal and external resources to plan and execute site project plans.
- Identifies, develops and executes facility and process improvement plans to improve efficiency, eliminate risk, improve safety and reduce costs by implementing new technologies and innovative solutions to address existing problems.
- Interfaces with other Site Leaders to coordinate maintenance and asset management programs.
- Interfaces with other designers and client representatives to supervise and coordinate the development of design deliverables.
- Develops, reviews and approves design documentation, including engineering calculations and drawings for HVAC, ductwork, process piping and plant utilities.
- Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work.
- Plans, monitors, and appraises direct reports, including performance competencies, goals & job results.
- Coaches, counsels, and conducts corrective action.
- Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
- Contributes to the overall operations and to the achievement of Site goals and objectives.
- Performs job-specific tasks in compliance with applicable Regulations, International Standards, and Company Policies and Standard Operating Procedures.
- Demonstrates thorough understanding of, and implements, Good Laboratory Practices and Good Manufacturing Practices.
- Other duties as assigned.
Qualifications:
Experience / Education
- Minimum 15 years of relevant experience or equivalent in pharmaceutical maintenance and/or engineering, preferably supporting drug substance operations
- Bachelor’s degree in Engineering, Master’s and PE preferred or equivalent experience
Knowledge / Skills / Abilities:
- Strong hands on leadership style
- Proficient in oral & written communication skills
- Demonstrated ability to read, write and speak English
- Proficient in Microsoft Office (Excel, Word, Outlook)
- 20% travel is required; both domestic and international
Physical Requirements:
- Must be able to work in an office environment with minimal noise conditions
- Must be able to wear appropriate PPE
- Must be able to work in an environment with variable noise levels
- Ability to stand/sit/walk for long periods of time
- Ability to lift 10 lbs routinely
- Ability to crouch, bend, twist, and reach
- Ability to push/pull 10 lbs. routinely / often / occasionally
- Clarity of vision
- Ability to identify and distinguish colors
- Must be able to perform activities with repetitive motions
- Ability to climb ladders / stairs / scaffolding
- Ability to work in variable temperatures (hot, cold, etc.)
- Ability to work both inside and outside in varying working conditions
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.