Scientific Products, an ATS Life Sciences Company is searching for an Engineering Manager to join our team!
The Engineering Manager will work closely with Project Management, Applications Engineering, Systems Engineering, Operations, Service teams, Technical Director and multi-discipline Engineering functions, both locally and at sister company sites, to develop and deliver customer and internal… projects. Manages a team of 14 to deliver approximately 20 projects annually, with project value ranging between $1m and $10m.
Responsible for optimizing design methods and providing engineering leadership for the safe production of pharmaceutical manufacturing equipment at the lowest possible costs. Beginning with quotation of new project opportunities through design / build / validation / production release of production freeze dryers and associated equipment, such as loaders, and for vial washing and processing systems. Focus is also required to help move SP to the next level in engineering design and execution, implementing a configure to order mentality through team development and critical review, plus improving all areas of work using LEAN tools from the ATS Business Model.
Responsible for all engineering project costs, maintaining schedules, and the effective management of the engineering group.
Analyzes and plans work force utilization, space requirements and workflow, and the design layout of equipment and workspace for maximum efficiency. Confers with planning and design staff concerning product design and fabrication to ensure efficient production methods.
Estimates production times, staffing requirements, and related costs to provide information for management decisions. Confers with engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes. Applies statistical methods to estimate future manufacturing requirements and potential.
Responsible for cGMP and GAMP5 design programs, execution thereof, and contribution and adherence to the QPP.
Co-ordinates team in developing tools to aid, and execute the detailed evaluation of requirements specifications and respond with functional, hardware and software specifications.
Responsible for ASME and PED pressure vessel design and quality control programs consisting of ASME and National Board Registration, compliance, execution and the generation and maintenance of the documented quality control program for same.
This position initiates, develops and implements innovative and cost-effective designs for systems, sub-systems and components of technologically complex equipment used in the pharmaceutical industry.
Maintains up-to-date knowledge of standards and regulations influencing aseptic packaging.
EXPERIENCE / QUALIFICATIONS:
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:
Experience working in a regulated industry
Knowledge and understanding of the following standards and regulations: FDA cGMP, ISPE GAMP5, ASME BPE, ISO 14644, GHS and EudraLex Vol 4 EU Annex 1
Experience in the application of configure-to-order and engineer-to-order
Demonstrated leadership skills and ability to drive change in a fast-paced work environment
Proven track record of creating, implementing and/or sustaining a lean operation
Extremely well organized with good project skills
Proficiency in the use of the Microsoft Office Suite including Word, Excel, Outlook, Project, PowerPoint, Visio
Proficient with SolidWorks and SolidWorks PDM suites.
Sound working knowledge of ERP systems
Has the ability to energize and motivate people and to effectively communicate with all levels of the organization
Has led organizations with a high level of integrity and accountability
Experience in developing, implementing and improving key performance indicator metrics through strong data analysis and continuous improvement
Proficiency in any of the following are an advantage; refrigeration design, computational fluid dynamic modelling with SolidWorks, pressure vessel design and manufacture.
LEAN, Six Sigma, TPS, or DMAIC experience is preferred
Demonstrated motivational and leadership skills
Excellent oral and written communication skills
Effective human relations and negotiation skills
Strong organization and project management skills
EDUCATION:
Bachelor's degree in engineering, MBA preferred, plus 8-10 years of experience with capital equipment, pharmaceutical equipment manufacturing, or chemical engineering; 5-7+ years of experience managing and developing people, preferably in the pharmaceutical/ project-related equipment industry
Experience and affiliation engineering and industry professional bodies is desired.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee is regularly required to talk and listen.
The employee is regularly required to use color vision and work with computerized data.
The employee is regularly required to stand, walk, and sit.
The employee is occasionally required to lift up to 20 pounds.
The employee is regularly required to use normal office tools, equipment and PC's.
WORK ENVIRONMENT:
The work environment characteristics described here are typical of those an employee might encounter while performing the essential functions of this job.
Work is normally performed in both the office and the shop.
The office environment is an interior office with air conditioning.
The shop contains mobile equipment, machinery, and high voltages.
The shop noise level is variable and may require hearing protection in some areas.
The shop is heated when required but many areas are not air conditioned.
Some shop processes use high voltage arcs or concentrated magnetic fields.
The shop contains open flames and caustic chemicals.
Why join Scientific Products?
We provide a wide range of innovative and high-quality scientific products that improve people's lives.
We offer a robust health and welfare benefits package that includes Life, Health, Dental, Vision.
We offer 401(K) including company match, Paid Time Off annually + Paid Holidays.
You will enjoy career Advancement Opportunities and Tuition Assistance to help you achieve your goals and continue your career growth.
We respect each other and foster a collaborative work environment.
We innovate and are open to change.
We are responsible, accountable and act with integrity.
WE LIKE WHAT WE DO!
EEO and Affirmative Action Statement:
SP is an Equal Opportunity Employer, dedicated to a policy of non-discrimination in employment on any basis and takes affirmative action to ensure equal employment opportunities. It is our policy to provide our employees and applicants with equal employment opportunities in accordance with applicable laws and not to discriminate on the basis of race, color, religion, ancestry, national origin, age, marital status, sex, gender identification, sexual orientation, genetic information, political belief, pregnancy, citizenship, handicap or disability, status as a veteran or member of the U.S. military, or any other characteristic protected by applicable federal, state, or local laws. SP's Affirmative Action Plan is available through the HR Department and may be accessed during normal business hours.
Pay Transparency Nondiscrimination Provision:
SP will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information