The Engineering Manager drives results in a fast-paced environment by developing and executing engineering and validation strategies supporting on-going and future modifications to facility, utility, manufacturing, and laboratory systems. Engineering includes but is not limited to project scope, cost estimates, schedules, design, procurement, installation/construction, and validation. Validation includes but is not limited to factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re-qualification. In addition, the Engineering Manager leads their team of engineers to ensure the strategic development of the organizational capabilities and growth. The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Your Responsibilities
Manages internal engineering and validation team and processes as well as provides engineering support to other groups including manufacturing and lab operations.
Cultivates an efficient, professional, and safe working atmosphere and ensures timely results are achieved.
Plans and directs all aspects of project engineering activities within the Germantown organization. Ensures all engineering projects, initiatives, and processes are in conformance with organization's established policies and objectives. Demonstrates API expertise in a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals.
Responsible for the management of capital projects, capital budgeting, and capital forecasting for the site. Manages the design, planning, construction, and maintenance of buildings, equipment, and other facilities. Plans, budgets, and schedules facility modifications including estimates on equipment, labor, materials, and other related costs.
Oversees the equipment, facilities and utilities validation program and drives innovation to remain current. Ensures all cGMP systems follow change control and validation requirements according to site procedures.
Leads the design, implementation, monitoring, control, and closure stages of major department and capital projects for the facility.
Leads and actively participates in client interface in regard to equipment, facility and utility lifecycle.
Oversees and develops the facility annual and long-term strategic capital investment plan and departmental operating budget.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Provides troubleshooting support as needed within a 24/7 operating environment.
Requirements for the Role
Bachelor's degree in engineering: Chemical, Mechanical, Biochemical, or equivalent required.
5-8 years of related experience required; 10+ years preferred.
Prior pharmaceutical experience required; prior API and CDMO experience preferred.
Expert knowledge in cGMP, engineering standards, methodologies and maintenance, project engineering, and validation lifecycle required.
What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.
Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent . Be willing. Be reliable.
