Engineering Jobs in Ayer Massachusetts
32 positions found — Page 4
Who We Are:
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
This role is the site SME responsible for coordinating all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while implementing effective cleaning strategies across the site. The position is integral to maintaining quality and safety standards in the manufacturing process, supporting both current operations and customer needs.
Core Responsibilities:
- Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities.
- Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants.
- Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness.
- Develop and maintain cleaning validation schedules to ensure timely completion of required validations
- Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements.
Scope:
- Will mentor and train other staff
- Lead by example in the quality organization
- Develop collaborative working relationships with all other departments and external customers
- Actively participate in daily cross-functional meetings, identifying risks to plan and develop recovery plans.
- Deliver on time results by prescribed due dates
- Demonstrates technical proficiency and self-assuredness in applying cGMP standards to all work
- Applies cGMP concepts in association with department specific responsibilities
- Ensures all documentation produced complies with in compliance with cGMP standards and all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.
- Responsible for developing, maintaining and updating internal policies and procedures
Qualifications:
Qualifications/ knowledge/ experience
(Technical/professional knowledge and skills competency)
- Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field
- Minimum of 3 years of experience in contamination control and cleaning validation, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable)
- Proven leadership experience in pharmaceutical, API/intermediate, drug product, biologics or related FDA industry
- Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control and cleaning validation with extended knowledge of microbial controls within a comprehensive cleaning program.
- Proficiency with risk assessment tools such as FMEA.
- Previous experience working in cross-functional and project-based environments.
- Experience creating metrics for driving continuous improvement
- Excellent analytical, written and verbal communication and presentation skills
- Hands-on experience with cleaning validation and bioburden reduction strategies
Personal skills and key competencies
- Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation
- Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks
- Proven experience working effectively in team situations and as an individual contributor
- Demonstrated behaviours that model the Veranova culture to achieve an inclusive environment and exceptional business results
- A mindset that promotes a positive work culture
- Excellent communication and interpersonal skills with the ability to lead, manage and develop cross-functional relationships
- Analytical mindset with a strong attention to detail and problem-solving skills
- Demonstrated excellent verbal and written communication skills
- Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities
- The ideal candidate will have hands-on experience with cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently
- Experience in a fast-paced work environment
- Certification in contamination control is highly desirable.
- Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9)
- Experience with continuous improvement methodologies such as Lean or Six Sigma desired
- Familiarity with purified water system design and validation
Salary Range: $125,000 - $140,000 annual base salary
Our Commitment:
- Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
- Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
- Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
- Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don’t meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
Buyer – Electrical Boxborough, MABuyer – Electrical Boxborough, MA
Experience level: Mid Level (5-8 yrs exp.)
Experience required: 4 Years
Education level: High school or equivalent
Job function: Purchasing
Industry: Medical Devices
Compensation: $71,000 - $90,000
Total position: 1
Relocation assistance: No
Visa sponsorship eligibility: No
Note: This role is Responsible for sourcing electrical components and assemblies.
We are seeking a Buyer for a manufacturing company in Littleton, MA. The Buyer plays a critical role on the Supply Chain team, responsible for procuring components, materials, and services essential to the design and manufacture of complex electromechanical systems.
Responsibilities
- Source, quote, negotiate, and issue purchase orders for a diverse range of commodities, including custom machined parts, cable and wire harnesses, PCBs, subassemblies, and specialized manufacturing services.
- Ensure materials and services comply with all applicable regulatory and quality standards (e.g., FDA, ISO 13485).
- Develop and maintain strong supplier relationships; conduct performance reviews, vendor visits, and improvement initiatives.
- Identify, evaluate, and qualify new suppliers
- Collaborate with Engineering and Production to support prototype builds, manage part obsolescence, and implement engineering change orders (ECOs).
- Perform cost analysis, contribute to make/buy decisions, and support cost-reduction initiatives.
- Monitor and report supplier performance in quality, delivery, cost, and responsiveness metrics.
- Expedite critical materials to maintain production schedules and minimize downtime.
- Participate in root cause and corrective action activities for supplier-related issues.
- Maintain purchasing records, documentation, and compliance with internal quality and regulatory systems.
- Compile and present purchasing metrics, cost savings, and procurement reports.
- Support internal and external audits as required.
Benefits:
- Competitive compensation
- Health, dental, and vision insurance
- 401(k) retirement plan with company match
- Paid time off and holidays
- Professional development opportunities
If you post this job on a job board, please do not use company name or salary.
- Competitive compensation
- Health, dental, and vision insurance
- 401(k) retirement plan with company match
- Paid time off and holidays
- Professional development opportunities
