Senior Project Engineer
Berkshire Sterile Manufacturing
Position Summary The Senior Project Engineer is responsible for leading and executing capital projects with a regulated pharmaceutical manufacturing environment. This role ensures projects are delivered safely, on time, within budget, and in compliance with cGMP and regulatory requirements. The position requires strong technical expertise, cross functional leadership, and the ability to manage complex projects from concept through commissioning and qualification.
Duties and Responsibilities
Duties and Responsibilities
- Lead capital projects for initiation through design, procurement, construction, commissioning, qualification, and closeout.
- Manage project scope, schedule, budget, and resources to ensure successful delivery of projects.
- Develop and maintain project documentation including User Requirement Specifications (URS), Functional Specifications, Design Specifications, and validation documentation.
- Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Validation, and Supply Chain.
- Oversee contractors, vendors, and external engineering firms to ensure compliance with project requirements and site standards.
- Identify project risks and implement mitigation strategies to minimize impact to schedule, cost, and compliance.
- Ensure alignment with regulatory requirements including FDA, EU GMP Annex 1, and internal quality systems.
- Participate in change control, deviation investigations, CAPAs, and risk assessments associated with projects.
- Support commissioning and qualification activities including FAT/SAT, IQ/OQ/PQ execution and documentation.
- Provide technical expertise in facilities, utilities, equipment, and process systems.
- Drive continuous improvement initiatives related to project execution, equipment performance, and operational efficiency
- Develop and present project updates and metrics to senior leadership
- Support capital planning, budgeting, and long-term site master planning activities
- Ensure adherence to safety standards and promote a strong safety culture throughout project execution
- Other duties as assigned
- Strong knowledge of pharmaceutical manufacturing systems, utilities, and equipment
- In-depth understanding of cGMP, regulatory requirements, and validation practices.
- Project management expertise including scheduling, cost control, and risk management
- Ability to develop and review engineering and validation documentation
- Strong problem-solving and analytical skills
- Excellent communication and leadership abilities
- Ability to manage multiple projects simultaneously in a fast-paced environment
- Proficiency with project management tools and Microsoft Office Suite
- Experience with change management and quality systems (e.g., MasterControl) preferred
- Ability to influence stakeholders and drive decision-making
- Maintain working knowledge of 21 CFR 210/211, EU Annex 1, and other applicable regulatory requirements
- Ensure all project activities comply with cGMP, data integrity, and company SOPs
- Support audit readiness and participate in regulatory inspections as required
- Ensure proper documentation, traceability, and compliance for all engineering and project activities.
- Provide technical leadership and mentorship to junior engineers and project team members
- Coordinate internal and external project resources without direct supervisory authority
- Influence cross-functional teams to achieve project objectives and timelines
- Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field) required
- Master's degree or professional certification (e.g., PMP) preferred
- Minimum ten (10) years of experience managing capital projects
- Minimum five (5) years of experience in pharmaceutical or regulated GMP environments
- Demonstrated experience managing complex facility, utility, and/or equipment projects
- Proven track record of delivering projects on time and within budget
- Experience with aseptic processing, cleanroom environments, and/or sterile manufacturing preferred
- Ability to sit or stand for prolonged periods of time
- Ability to lift and carry materials weighing as much as 50lbs
- Ability to stand and walk in manufacturing and construction environments as required
- Ability to meet cleanroom gowning requirements.
- Ability to travel between facilities or vendor sites as needed
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Project Engineer in Lee, MA vacancy
$60k - $100k
...Audit Senior Opportunity If you are a proven and experienced Audit Senior who can add your expertise to a top local CPA firm, a great opportunity awaits in the area. This well-respected and growing CPA firm is searching for an Audit Senior who will add significant...SeniorFull timeLocal areaWork from homeFlexible hoursgpac
Tyringham, MA1 day ago$21 - $26 per hour
Canyon Ranch Culinary Team MemberCanyon Ranch® has been a trailblazer and an industry-leading proponent of the wellness lifestyle since its founding in 1979. Canyon Ranch has imparted integrative expertise to millions of guests, with established wellness destination resorts...SeniorShift workNight shiftCanyon Ranch
Lenox, MA1 day ago$177.69k
...Senior Account ExecutiveLee, MAAbout the OpportunityThis isn't a traditional sales role; it's a chance to build and operate a hyperlocal magazine in your community, backed by the support of an established national company. You'll build something of your own: developing...SeniorLocal areaWork from homeHome officeThe N2 Company
Lee, MA1 day ago$87k - $120k
...or an alternative application process. Senior Formulation Scientist Full Time Lee, MA,... ...master batch records, study protocols, engineering batch record, process characterization reports... ...to conduct analyses of research projects, interpret test results or develop procedure...SeniorFull timeWork at officeSharp Services Inc
Lee, MA2 days ago- ...Job Description Position Summary The Senior Manager, Data Integrity & Governance is... ...including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance... ...capable of prioritizing and managing multiple projects effectively. The successful candidate...SeniorWork at office
SHARP STERILE MANUFACTURING LLC
Lee, MA17 days ago $18.25 - $24 per hour
Join to apply for the Certified Senior Pharmacy Technician role at Walgreens 2 days ago Be among the first 25 applicants Join to apply for the Certified Senior Pharmacy Technician role at Walgreens Get AI-powered advice on this job and more exclusive features. This range...SeniorHourly payFull timeApprenticeshipWork experience placementLocal areaImmediate startFlexible hoursAfternoon shift- ...(e.g., water test results, receiving POs, etc.) in a timely manner within the aquatic department. Performs additional duties and projects as required or assigned with or without regular supervision. Other Essential Duties UTILIZE SELLING BEHAVIORS . You're the key to...SeniorLocal areaNight shift
PETCO Animal Supplies Stores, Inc.
Pittsfield, MA4 days ago $203.85k - $220.57k
...Recognized ability to build relationships with senior level customers and internal... ...techniques and evaluation criteria for projects, programs, and people Ensures budgets... ...General Dynamics Mission Systems (GDMS) engineers a diverse portfolio of high technology solutions...SeniorImmediate startRemote workFlexible hoursProgeny Systems Corporation
Pittsfield, MA1 day ago$124.4k - $138k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics field. Also requires 5+ years of job-related experience, or a Master's degree plus 3 years of job-related experience. Agile experience...Flexible hours$125.06k - $135.32k
...including Program Manager - Subcontracts, Engineering, Finance, and other disciplines to... ...independent judgment, and professionally executes projects with little direction. Acts... ...contacts outside own area of expertise and senior internal and external personnel in own area...SeniorContract workFor contractorsFor subcontractorWork at officeFlexible hours2 days per weekProgeny Systems Corporation
Pittsfield, MA2 days ago- ...Senior Network & Systems Engineer At General Dynamics Mission Systems, we create the technologies, products and services that help our nations... ...with the best and your talent will be front and center on projects that impact the world. Are you up to the challenge? We...Senior
General Dynamics
Pittsfield, MA3 days ago - ...pricing, and formulation value to support margin expansion and volume growth. Partner with TS&D to prioritize and advance key portfolio projects, with emphasis on broad market opportunities. Support planning, execution, and development of commercial-ready outputs and...SeniorPermanent employmentWork experience placementLive inVisa sponsorship
Dow Chemical
Pittsfield, MA2 days ago $86.21k - $141.64k
...supports Guardian’s growth strategy by delivering high-impact recruiting outcomes across business groups. The position works closely with senior leaders, Talent Partners, and Centers of Expertise to shape hiring strategies aligned to business priorities, workforce plans,...SeniorFull timeWork experience placementH1bWork at officeImmediate startWork from homeVisa sponsorshipWork visaFlexible hours3 days per week$174.65k - $193.75k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum... ...Systems Engineering Knowledge, strong Communication Skills to senior leaders, deep understanding of Navy Strategic Systems Programs...SeniorFlexible hours- ...passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing... ...concepts, specifications, design engineering, documentation, project implementation, testing, startup, and training of operating and...Local areaFlexible hours
E Tech Group
Pittsfield, MA4 days ago - ...information resource regarding system input. Performs additional duties, departmental cross-training and participates in special projects as required. Ensures compliance with all banking laws, rules, regulations, and prescribed policies/practices/procedures...SeniorWork experience placementWork at office
Beacon Bank
Pittsfield, MA4 days ago $85.24k - $94.56k
...Sr Quality Engineer Imagine a world-class engineering environment with exceptional talent and advanced technologies that are often classified. At General Dynamics Mission Systems, you'll work with amazing engineers to invent the technologies, products, and services...SeniorRelocation packageFlexible hoursProgeny Systems Corporation
Pittsfield, MA8 hours ago$100.22k - $111.18k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics... ...for this Position ROLE AND POSITION OBJECTIVES:As a senior systems engineer for the NWS program, you’ll be a member of a...SeniorSecond jobFlexible hours$94.06k - $104.34k
...Senior Manufacturing Engineer Help make the technologies, products and services that make a difference. That's the opportunity that's waiting for you at General Dynamics Mission Systems. We help our nation's heroes keep our nation safe by creating solutions so advanced...SeniorFlexible hoursProgeny Systems Corporation
Pittsfield, MA1 day ago- ...implementation, testing, deployment, and maintenance. Collaborate with cross functional teams including business analysts, QA engineers, and project managers to deliver high quality solutions on schedule. Troubleshoot and resolve complex technical issues in a timely...Senior
$120k - $130k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics field. Also requires 5+ years of job-related experience, or a Master's degree plus 3 years of job-related experience. Agile experience...SeniorRemote workFlexible hours$118.52k - $131.48k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 5 years of relevant experience; or Master's degree, plus a minimum of 3 years of relevant experience.CLEARANCE REQUIREMENTS:Department...SeniorWork at officeFlexible hours$106.48k - $115.21k
...Qualifications Requires a Bachelor’s or Technology degree in Engineering or a related specialized area/field, or equivalent (4 years... ...technical goalsMentoring engineering leaders across technical and project management topicsEngineering leadership; excellent...SeniorRelocation packageFlexible hours$112.92k - $125.28k
Basic Qualifications Bachelor's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 5 years of relevant experience; or Master's degree, plus a minimum of 3 years of...SeniorWork at officeFlexible hours3 days per week$118.52k - $131.48k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 5 years of relevant experience; or Master's degree, plus a minimum of 3 years of relevant experience.CLEARANCE REQUIREMENTS:: Must...SeniorWork at officeFlexible hours- Job Description Job Description UNIVERSAL FAMILY INSURANCE (UFI) , a NorthStar Fertility Company, is an established Lloyd’s of London Coverholder specializing in third party reproductive medical insurance risk management with offices in Boston and Great Barrington,...SeniorWork at office
$100.22k - $111.18k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum... ...changing business needsSupport and engage in programs, projects and practices behind the General Dynamics Mission Systems culture...SeniorFlexible hours$118.52k - $131.48k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics... ...for hardware and/or software compatibilityPlan and execute project tasks, contribute to major program milestones, and support the...SeniorWork at officeFlexible hours$105.81k - $117.39k
Basic Qualifications Bachelor's degree in Engineering, or a related Science or Mathematics field, plus a minimum of 5 years of relevant experience; or Master's degree plus a minimum of 3 years of relevant experience.CLEARANCE REQUIREMENTS:Department of Defense Secret...SeniorFlexible hours$146.6k - $154.4k
...Qualifications Education Requirements:Bachelor's degree in Software Engineering, or related Science, Technology, Engineering or Mathematics... ...for this Position ROLE AND POSITION OBJECTIVES:As a Senior Software Engineer engineer for the AI Reliability Engineering...SeniorContract workRemote workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Project Engineer. Be the first to apply!
