The Manager, Manufacturing Engineering will be responsible for leading the Engineering management function for the Antares Pharma manufacturing facility as well as sustaining engineering support for supply chain. The successful candidate will be responsible for the implementation of Engineering projects related to manufacturing process equipment and facilities infrastructure. The successful candidate will lead a team in applying engineering principles to the manufacturing of clinical and / or commercial stage complex drug products. Additional responsibilities may include project engineering oversight of contract manufacturing organization (CMO) oversight for engineering related outputs. The individual will have a history of success in the Medical Device industry with demonstrated mechanical engineering and commercial manufacturing process development skills. This Engineering management leader will be well versed in evaluating alternatives, establishing priorities, risk management, statistical process capabilities / analysis / decision making, the management of the Commissioning, Qualification, and Validation (CQV) lifecycles for equipment and processes. The successful candidate will have superior interpersonal skills with the ability to effectively gain credibility and trust with his/her technical and commercial peers, as well as their teams across the organization and external collaborators.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
Oversees engineering design, acquisition, installation, start-up, and disposition of production equipment, as well as building systems, by partnering with manufacturing, facilities, validation and quality assurance functional groups.
Develop and maintain commercial manufacturing processes to meet or exceed established standard production rates.
Support commercial manufacturing Quality and Quality Management systems requirements, such as Corrective/Preventive Action(s) management, complaints investigations, non-conformance (deviation) investigations and product disposition.
Manage day-to-day oversight of engineering support of the internal manufacturing operations, integrate engineering support with supply chain team to minimize line down occurrences at CMOs.
Manage capital improvement projects for facility construction and renovation.
Work with Engineering leadership team to set proper direction for manufacturing process development to be consistent with Antares goals and those of their partners.
Build, coach, mentor and develop a team of process engineers that are professionally and technically competent in world-class manufacturing engineering principles and methodologies.
Develop effective relationships and work closely with a broad and diverse range of customers, including equipment vendors, pharmaceutical companies and manufacturing partners, to ensure a deep and current understanding of the products and markets Antares serves.
Support site during audits from regulatory bodies, clients, corporate and/or internal personnel, or any other inspection deemed to warrant engineering input.
Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
A bachelor’s degree in an accredited engineering or technology related field is required. A master’s degree in engineering and/or business administration is preferred.
YEARS OF EXPERIENCE:
8+ years of experience working in an engineering capacity in an industrial manufacturing setting, preferably medical device or pharmaceutical industry.
3+ years of experience managing a team in an engineering capacity, preferably in the Medical Device or Pharmaceutical industries.
3+ years of experience in supporting manufacturing lines for the production and packaging of Medical Device and / or Pharmaceutical products.
2+ years of experience managing capital projects for equipment procurement, facility construction, expansion or renovation, preferred
OTHER SKILLS AND ABILITIES:
Strong knowledge of GMP, ISO, GAMP 5, ISPE and other applicable international regulations, standards, Directives and Guidance required
Exhibits strong leadership attributes in the areas of making complex decisions, keeping on point, managing complex work processes, focusing on actions and outcomes, and managing diverse internal and external relationships.
Thrives in a fast-paced environment with the ability to manage multiple projects concurrently, either through independent or team-based work approaches.
Experience with high pressure situations and participation in audits or inspections.