Director/VP of Engineering and Validation
Berkshire Sterile Manufacturing (BSM) provides individuals the opportunity to grow their career at a fast-paced, industry leading and entrepreneurial contract manufacturing organization within the biotech and pharmaceutical industries.
BSM is located 45 minutes from the Albany, NY and is just two hours from greater Boston and three hours from NYC.
Benefits include an onsite day care, professional development opportunities and day one insurance.
In this hands on senior leadership role at our growing CMO, you will report directly to the CEO and be responsible for cGMP plant calibration and maintenance, commissioning, qualification, and validation, and capital engineering.
This role requires 8+ prior industry specific experience, a demonstrated track record of success and professional development, a strong sense of business ownership towards the pursuit and completion of engineering projects and programs within budgetary guidelines while maintaining the standards of engineering excellence.
Exciting compensation and benefits package including day one health insurance, bonus program, SARs, 401(k), onsite subsidized day care, tuition reimbursement and more!
Education and Experience
- BS in a related field of science/engineering
- Eight or more years industry experience including
- cGMP experience
- Pharmaceutical validation.
- Management and training of direct report
- Experience working in small to medium sized biotech or pharmaceutical organization or contract manufacturer strongly desirable
- Hands on leadership
- Adept interpersonal and communication abilities at a senior leadership level
- Thoughtful and decisive decision making.
- Microsoft office applications (Word, Excel, PowerPoint, Visio) and other related software.
- Attention to detail
- Ability to see the "Big Picture"
- Budgeting experience
- Able to travel to customers and/or other contractual facilities as needed.
- Flexibility to work overtime to meet business requirements.
- Oversight and control of all work activities related to engineering and validation.
- Ongoing establishment and/or review of technical design, criteria, and specifications for all cGMP facilities, mechanical systems, and utilities; communicates to other engineers through standard details.
- Direct the development of new methods or techniques.
- Work with suppliers and to develop new technical concepts.
- Maintain contact with client representatives to ensure good communication and satisfactory progress of contract deliverables.
- Represent engineering in key interdepartmental and client conferences.
- Perform site assessments, documents observations/findings.
- Develop short and long term strategic planning improvements and oversee improvements.
- Budgetary responsibilities for department.
- Lead recruiting, selection, training and performance management for department.
- Oversight of 1099 contractors.
- Conduct business in a responsible manner that complies with all state, FDA, OSHA, cGMP, EU or other regulations, as applicable.
- Maintain continued education and proficiency through education, literature and seminars.
- Ability to meet gowning requirements
- Ability to occasionally lift up to 50 lbs.
- Ability to walk and climb
- Fine and gross motor skills
- Satisfactory audio-visual acuity